Associate Director,Clinical Operations

US Discovery
San Francisco Bay Area
Primary Function:

The Associate Director, Clinical Operations is accountable for the planning and execution of assigned development global clinical trials (includes First-In-Human, Phase 1b, and other signal-seeking Phase 1 trials) under the direction of the Director/Senior Director, Clinical Operations. The Associate Director is a member of one or more cross-functional Zai Project Teams (ZPTs). These complex programs focus on the rapid development of NMEs with limited clinical data, and as such, require the implementation of novel and highly flexible global operational strategies to support exploratory hypotheses, including biomarkers and diagnostics. This is a developing leadership role that will increasingly demonstrate the ability to work independently, problem-solve, effectively collaborate, and innovate.

Major Responsibilities and Duties:

- Lead and coordinate a global cross-functional study team following the RACI framework through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan.

- Accountable for the overall operational delivery (e.g. country and site selection/start-up, site contracts, patient recruitment and retention, etc) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline and budget requirements.

- Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs. Liaises with cross-functional team members including the ZPT members to solicit input.

- Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.

- Ensures TMF creation and QC completion.

- Supports EDC, IxRS, and CTMS systems and data maintenance.

- Tracks budget, timelines, milestones, and critical study activities,  identifies issues and proposes potential resolutions.

- Partners closely with medical in designing global clinical trial protocols and provides strategic operational input on protocol feasibility.

- Provides input to the study budget and manages assigned vendor budget(s);  communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution.

- Participates in the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale.

- Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.

- Leads the Investigator Meeting preparation and execution with the support from cross-functional team members.

- Participates/serves as a subject matter expert for business and/or functional initiatives.

- Stays current on relevant therapeutic area knowledge and clinical research best practices.

- Ensures study adherence to ICH/GCP and company SOPs.

Qualifications:

- Undergraduate degree in a scientific or health-related discipline.

- Minimum of 7+ years relevant clinical experience in the pharmaceutical industry, including 2 years in study management experience, or equivalent combination of education, training, and experience.

- Demonstrated ability in clinical study management processes and clinical/drug development.

- Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders.

- Experience with effective vendor management.

- Demonstrates strategic thinking skills; manages risk (including risk identification and mitigation); identifies critical path/critical dependencies.

- Strong customer focus with investigators, functional peers, vendors, etc.

- Excellent planning and organizational skills.

- Ability to build trusting and collaborative relationships globally.

- Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.

- Willingness to travel domestically and internationally and work across cultures.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com



Biosample OperationsManager

US Discovery
San Francisco Bay Area
Primary Function:

The Biosample Operations Manager (BOM) will act as the SME for all biological samples collected during a clinical trial. We are seeking an experienced BOM to support translational and biomarker activities for Zai's rapidly growing pipeline of small and large molecules in early-through late-stage clinical development. You will be accountable for the execution of the biomarker strategy that includes the planning and coordination of all operational activities required for the collection and delivery of clinical trial samples (Biomarker/CDx, PK, PD, ADA) for assigned studies. The BOM works closely with the Study Team Lead, CRO partners, Site Monitors, Clinical  Pharmacology, Translational Medicine, etc. to ensure the study protocol and overall program deliverables are met.

Major Responsibilities and Duties:

- Drives the implementation and execution of the clinical biomarker and diagnostic plans for clinical programs in early and late-stage clinical development across therapeutic areas.

- Accountable for planning, organizing, and overseeing the collection and shipping of biosamples from Investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality. The BOM will also oversee the assay laboratory, ensure delivery of assay results, and is the primary contact for the assay lab.

- Manage key vendors and CROs to support clinical sample collection, assay laboratory services, sample storage, and/or biomarker analysis including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals.

- Determine timelines and resource needs for all biosample operational activities, ensure these are included in study plans, and are appropriately tracked.

- Write the Study Sample Management Plan to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type.

- Accountable for ensuring that data received is consistent with the collection and assay plans and protocol.

- Provide input to clinical study protocol and ICF to review for collection and analysis rationale, the feasibility of biological sampling, and alignment with Zai Lab policies and study/program plans.

- Utilize operational and project management skills to think through issues to ensure deliverables are met; raise issues to study team lead, translational medicine scientist as needed.

- Maintain oversight of all study biosample operational activities and regularly report on status (including reconciling against consent).

- In coordination with Clinical Operations, provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, presenting sample collection requirements at Investigator Meetings, or training of sites on collection procedures.

- Monitor effectiveness of Investigator site sample handling training and quality of samples received and recommend corrective actions as necessary.

- Ensure study adherence to ICH/GCP and SOPs.

- Identifies areas of best practice and process improvements. 

Qualifications:

- Life Sciences degree (higher qualification e.g. MSc or Ph.D. preferred).

- 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.

- Competent in the application of standard business procedures (standard operating procedures (SOPs), International Conference on Harmonization (ICH),  Global Regulations, Ethics, and Compliance).

- Extensive clinical development experience of working in teams running clinical studies, particularly in oncology and/or immuno-oncology early drug development.  Successful track record in oncology employing tissue (e.g., IHC, ISH) as well as genomic biomarker endpoints from tissue and blood samples, including NGS, PBMC-based analysis, FACS, and plasma biomarker analyses.

- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.

- Critical reasoning skills including the identification and resolution of complex problems.

- Detailed-oriented with the ability to work independently and manage competing priorities.

- Excellent planning, organizational, and time management skills.

- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.

- Effective communication and presentation skills.

- Proven ability to build and maintain effective working relationships.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com


Senior Director /Director, Clinical Operations

US Discovery
San Francisco Bay Area
Primary Function:

The Senior Director/Director, Clinical Operations is responsible for leading the  strategy, planning, and implementation of clinical development programs in the Clinical Operations organization and contributing as the lead program level representative to the Zai Project Team (ZPT). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility, and financials) perspective to meaningfully contribute and make recommendations to clinical development plans to advance Zai Lab clinical programs. The Senior Director/Director, Clinical Operations helps define and implement vision and strategy for study management and is accountable for functional management including recruiting, building, and maintaining a high-quality clinical operations function.

Major Responsibilities and Duties:

- Through appropriate leadership, direction, and operational expertise, lead the development and execution of global operational strategies for multiple molecules/programs in Zai Lab's development portfolio.

- Recognized as an expert thought partner in drug development with a thorough  understanding of all aspects of clinical drug development.

- Core member and Clinical Operations representative on the Zai Project Team serving as a primary consultant to senior-level colleagues, functional leadership, and cross-functional stakeholders.

- Contributes to the development of the clinical development plans and establishes the operational plan for a new program of study including scenario planning, high-level forecasting of timelines, assessment of program-level feasibility, estimation of resources and budget, and development of high-level operational strategies.

- Accountable for meeting all operational deliverables following time, cost, and quality commitments. Maintains an overview of the status, issues, and proactively communicates progress, issues, or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program.

- Provides program leadership to global cross-functional teams including external partners and vendors through oversight, guidance, strategies, and direction to achieve results.

- Provides innovative and flexible operational solutions with the ability to understand, critically assess and influence clinical development plans, protocol design, resource needs, budgets, and timelines for programs.

- Provides disease area expertise and input while anticipating changes in the disease landscape (e.g. standard of care) and regulations that impact operational strategies.

- May be assigned to one or more complex programs.

- Provide leadership, guidance, and manage performance and development of direct reports; administer performance programs following policies and ensure the development of potential succession candidates.

- Identify, recruit, and hire Clinical Operations Study Team staff, as well as oversee their work to ensure all goals, deliverables, and objectives are met; 30% of time spent leading and managing people.

- Ensure that employees are appropriately trained, developed, and coached to comply with company policies and Global regulations.

- Participate in and/or lead business improvement efforts within the Clinical Operations organization to improve clinical trial processes, systems, methodologies, and tools.

- Lead by example to create a positive work environment by encouraging mutual respect, innovation, smart risks, and accountability on a functional and project level, both locally and globally, to help the organization continuously evolve, improve, and excel.

Qualifications:

- Undergraduate degree in a scientific or health-related discipline. Advanced scientific or business degree (MS/Ph.D./PharmD/MBS/MPH) preferred.

- Minimum of 10 years (12+ for Senior Director) experience in drug development,  clinical research, and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines, and budget.

- Demonstration of project/program management skills including risk assessment, timeline, and budget management, and contingency planning.

- Prior functional management experience.

- Excellent communication, management, and organizational skills, along with problem-solving, conflict resolution, and team-building skills.

- Experience across several complex therapeutic areas. Scientifically and clinical agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery.

- Ability to set clear vision/strategies and removes obstacles for teams that are barriers to doing productive/high-impact work.

- Proven ability to coach, develop, manage performance, and mentor personnel.

- Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.

- Willingness to travel domestically and internationally and work across cultures.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com



Principal Scientist/ Associate Director

US Discovery
San Francisco Bay Area
Primary Function:

We are seeking an energetic and self-motivated PhD-level scientist to join our Biology team focusing on the identification, validation, and advancement of novel cancer therapeutic candidates. The candidate will lead a new team focused on providing expertise in immunohistochemical techniques to support existing and emerging therapeutics. 

Major Responsibilities and Duties:

Develop expertise at Zai Lab in various techniques focused on examining biomarker expression in tissue. Since this is a new functional team, it will involve establishing an operating budget, purchasing required equipment, and identifying potential CRO's to support our work. Hands-on work may include immunohistochemistry, immunofluorescence, and in situ hybridization on human and rodent tissue to determine target and biomarker expression. Support ex vivo analysis to examine drug pharmacodynamics and inform biomarker discovery. Develop new assays to support validation and advancement of projects in the discovery and preclinical development stages. Analyze and present data as well as rationale and design of in vitro studies to the department and project teams. Manage and direct the activities of a group of research associates. Work collaboratively on multiple projects concurrently and coordinate activities across functions.    

Qualifications:

1)    PhD equivalent with expertise in analyzing protein/mRNA expression in tissue.

2)    At least 5-8 years of relevant post-PhD or 10+ years post-MS experience, preferably in the pharmaceutical industry.

3)    Expert in tissue-based biomarker development and analysis, including immunohistochemistry, immunofluorescence, and in situ hybridization.

4)    Proven track record of innovation, scientific excellence, and integrity.

5)    Excellent management and training skills.

6)    Capable of working independently in a fast-paced, team-oriented environment, demonstrating multitasking capabilities.

7)    Flexibility to accommodate to rapidly changing priorities and deadlines.

8)    Excellent troubleshooting and data analysis skills are required.

9)    Great communication skills and team spirit is a must ability to communicate results within pharmacology team and at project team meetings required.

10)   Previous industry experience is preferred.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com



Research Associate/ Senior Research Associate

US Discovery
San Francisco Bay Area

Primary Function:

The successful candidate will be part of a  Biology team focusing on the identification, validation, and advancement of  novel therapeutic candidates that are designed to modulate the immune system to target cancer cells. The candidate will perform hands-on experiments in vitro and ex vivo to examine target expression, mechanism of action, and potency of our emerging IO therapeutics.

Major Responsibilities and Duties:

Provide experimental support and immunology expertise for discovery and validation of new drug targets and preclinical development for existing projects in the immuno-oncology space.Perform experiments using various in vitro and ex vivo model systems/assays to examine target expression on various immune cells. Hands-on work will include cell culture, generating and utilizing immune cell assays, and performing various assays, including flow cytometry, Western blot, and ELISA.Support ex vivo analysis to examine drug pharmacodynamics and biomarker discovery.Analyze and present data as well as rationale and design of in vitro studies to the department and project teams.Work collaboratively on multiple projects concurrently and coordinate activities  across functions.    

Qualifications:

1)    Bachelor's or Master's degree in Biology/Oncology.

2)    At least 1-5 years of hands-on in vitro experience in immunology, cancer biology, and/or immuno-oncology  is required, preferably in the biotechnology or pharmaceutical industry setting.

3)    Basic cell culture and assay development experience is required.

4)    Hands-on experience with various in vitro laboratory techniques required, including Western blot, qRT-PCR, ELISA, immunohistochemistry, and flow cytometry.

5)    Capable of working independently in a fast-paced, team-oriented environment, demonstrating multitasking capabilities.

6)    Excellent troubleshooting and data analysis skills are required.

7)    Great communication skills and team spirit is a must; ability to communicate results within pharmacology team and at project team meetings required.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

   

Research Associate/ Senior Research Associate

US Discovery
San Francisco Bay Area

Primary Function:

The successful candidate will be part of an in vivo pharmacology team focusing on the validation and advancement of novel cancer therapeutic candidates. The candidate will perform hands-on experiments on rodents to examine the efficacy and mechanism of action of our anticancer therapeutics.

Major Responsibilities and Duties:

Perform in vivo studies to test oncology and immune-oncology therapeutics. Hands-on work will include cell culture, generating xenograft tumor models, intravenous (IV), intraperitoneal (IP), and intragastric (PO) dosing of mice, as well as isolation of mouse blood (via various routes) and tissues. Support ex vivo analysis to examine drug pharmacodynamics and biomarker discovery. Analyze and present data as well as rationale and design of in vivo studies to the department and project teams. Work collaboratively on multiple projects concurrently and coordinate activities across functions.    

Qualifications:

1)   Bachelor's or Master's degree in Biology/Oncology.

2)   At least 1-5 years of hands-on in vivo experience with mice, including generating and measuring xenograft  tumors, dosing via intravenous, intraperitoneal, and intragastric administration,  and collection of mouse tissue and blood is required.

3)   Basic cell culture experience is required.

4)   Hands-on experience with various in vitro  laboratory techniques will be a plus, including Western blot, qRT-PCR, ELISA,  immunohistochemistry, and flow cytometry.

5)   Capable of working independently in a fast-paced,  team-oriented environment, demonstrating multitasking capabilities.

6)   Excellent troubleshooting and data analysis skills are required.

7)   Great communication skills and team spirit is a must; ability to communicate results within pharmacology team and at project team meetings required.

8)   Previous industry experience is a plus.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

Scientist/Senior Scientist, Bioinformatics

US Discovery
San Francisco Bay Area
Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 850 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.

Zai Lab is seeking an innovative computational biologist to help drive Zai Laboratory's translational efforts. This will include aiding the identification of new targets, developing patient stratification strategies, and helping guide the development of Zai's clinical pipeline. The successful candidate will have a proven track-record of converting multi-omic datasets into clinically actionable insights.

This position is in Menlo Park, CA.

Responsibilities:

- Collaborate in leading computational efforts with multi-disciplinary teams, and apply cutting-edge computational approaches to gain maximum insights from large, multi-omic pre-clinical, clinical, and real-world datasets.

- Collaborate with cancer biologists, immunologists, chemists, statisticians, and develop computational strategies and build tools for target discovery, patient stratification, and development of pharmacodynamic and predictive genomic signatures.

- Effectively communicate findings at internal and external meetings.

- Contribute to building a culture that embraces continuous learning and improvement and disease biology expertise.

Qualifications:

- Master's in computational biology, engineering, statistics, cancer biology, immunology, genetics, or similar field, with 8+ years of experience.

OR

- Ph.D. in computational biology, engineering, statistics, cancer biology, immunology, genetics, or similar field, with 2+ years of experience.

- Experience analyzing multi-dimensional genomic and/or proteomic datasets from clinical and preclinical samples.

- Expertise performing data analysis using Python or R, as well as setting up *nix-based systems for data analysis such as Jupyter Notebook servers.

- Strong data science skillset. Familiar with statistical methods such as data normalization techniques, distribution comparison, enrichment analysis, clustering methods, and multiple hypothesis correction.

- Expertise with at least one data visualization package such as matplotlib, plotly, vega, or ggplot.

- Excellent independent problem-solving and collaboration skills.

- Ability to clearly communicate computationally-derived results with non-bioinformaticians.

Preferred Qualifications:

- Clinical development and/or biopharma industry experience.

- Experience generating robust predictive and/or prognostic signatures highly desired

- A strong background in oncology and/or immuno-oncology.

- Current experience with NGS-processing software such as samtools, RSEM, and/or STAR.

- Familiarity with a variety of database query languages (both SQL and NoSQL).

- Experience with big data tooling (e.g. Spark) and/or distributed computing systems (e.g. Kubernetes).

- Strong interpersonal ability to work collaboratively in a cross-functional team setting.

- Strong track record of productivity, as evidenced by driving project forward and robust publications.

- Enthusiastic, open-minded, and active in scientific development and personal growth.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

Associate Manager/Manager, Procurement

Finance
San Francisco Bay Area
Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 850 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year. In September 2020, Zai Lab U.S. moved to a new, larger research facility to accommodate our continued growth.

Zai Lab is recruiting for an Associate Manager/Manager, Procurement to support our US entity. This role reports to Associate Director, Finance. This position is in Menlo Park, CA.

Responsibilities:

- Manage all purchasing activities related to US entity, follow standard purchasing processes and procedures, and improve as needed

- Build efficient and effective relationships with vendors with the intent on a long-term, mutually beneficial relationship, with a focus on key vendors

- Negotiate with vendors to secure advantageous terms and savings

- Collaborate with business departments and research teams to ensure clarity of expectations and specifications.

- Perform other duties, as assigned

Qualifications:

- Bachelor's degree and 5 years of experience OR Master's degree and 2 years of experience
- 4+ years of relevant experience as a sourcing or procurement professional preferably in Biotech or Pharma industries

- Strong written and verbal communication and negotiation skills, and the ability to work well with vendors and colleagues    

- Familiar with sourcing and procurement systems and best practices

- Effective time management and organizational skills

- Ability to navigate in a dynamic, fast-paced environment with multiple priorities

Preferred Qualifications:

- Vendor relationship management and procurement experience supporting preclinical and Clinical operations

- Experience with establishing MSAs/preferred partnerships

- Governance/oversight processes to ensure delivery

- Chinese language skills

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

 

(Associate)Brand Communication Manager (new product)

Communications
Shanghai

Job Description:

1. Develop communication strategy & plan for each brand which is aligned with business goals.

2. Manage the program/activities and responsible for the good results in align with the plan.

3. Work independently to supervise agency to develop executional plan including budgets for assigned projects.

4. Supports manager to conduct issues management for each brand and provides proactive, strategic external affairs recommendations and issues management counsel and recommendations to relevant Commercial Leadership Teams.

Qualifications:

1. Bachelor degree and above (major in journalism, English, communication or media field is preferred).

2. Good writing skills in Chinese for release, editorial story development.

3. Good language skills for oral and written English.

4. Good interaction and influencing skills with various stakeholders including internal (marketing, medical, commercial and global colleagues) and external (media, KOLs and industry associations).

5. At least 5 years work experience in product communication or marketing in MNCs, PR agency or related fields preferred.

6. Solid and hands-on experience in planning, copywriting and media management.

7. Good communication & interpersonal skills (with both internal and external stakeholders).

8. Good project management skills on planning, execution, agency management, creativity, cross-function coordination.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

(Sr.) Direcor,Biologics Pilot Plant

Pilot Plant
Suzhou

Job Description:

1) Oversees the development and maintenance of an established system to show the hierarchy of plans and schedules; keeps project and company management fully informed and be able to prioritize tasks assigned to pilot plant.

2) Coordinates staffing requirements, assigns and supervises project work activities, and trains personnel.

3) Completes performance reviews and provides personnel development for the assigned employees and support yearly manufacturing budgeting efforts.

4) Participates in business development efforts by gathering and presenting a variety of background data. May be required to make informal or formal presentations.

5) Leads capability assessment and activities to drive continuous improvement in the site operations.

6) Responsible for building plan and execution of cost saving plans.

7) Critical participant on Risk Assessments for new product manufacturing processes.

8) Oversee Sites Health, Safety and Environmental programs, as well as Reliability and Sanitation workstreams.

Qualifications:

1) MS or Ph.D. (preferred) degree in Biology, Biochemistry, Chemical Engineering, or related field (or equivalent work experience)

2) 8-12 years of related experience in pharmaceuticals or Biotech, proven cGMP knowledge and working experiences, as well as strong team management experience in a supervisory position for at least for 8 years.

3) Proficient PC skills including a proficiency in various Project Controls Software and Microsoft Office Suite.

4) Proven ability to perform in a supervisory capacity, as well as thorough knowledge of industry practices is required.

5) Good English skills in writing, reading, and speaking as plus.If you are interested in this position, please send an email with your resume to talent@zailaboratory.com 

ProductManager-Zejula

Marketing
Shanghai

Job Description:

 Understand overall brand strategies of owned product.

 Explore the insight and contribute to brand plan and budget control.

 Build the brand image in nation and provide direction and insight related to tactical thought of regional market issues.

 Identify regional opportunities and potential trend through regional market data interpretation to improve the market share.

 Lead the brand key pilot rolling out and execution of regional unique activities.

 Identify marketing competitor landscape, provide regional competition strategy and implementation plan.

Qualifications:

 Master’s degree or above on pharmaceutical, clinical medicine or clinical medicine related with outstanding English.

 At least 5 years working experience in marketing position.

 At least 2 years in TA of ONCO or specific drug, digestive field is preferential.

 Excellent market analytical & problems’ solving skills with strong planning skill.

 High logicality with quick learning capabilities and a good work ethic with strong communication and interpersonal skills.

 Capability to work under pressure & perform duties with high quality timely.If you are interested in this position, please send an email with your resume to talent@zailaboratory.com 

NGOManager

GAD
Shanghai

Job Description:

1. Select and evaluate NGO, engage key stakeholders of qualified NGO and internal functions to get all preparation on time, including donation scheme, inclusion criteria, donation goods supply and donation agreement, etc., and launch patient support program on schedule.

2. Collaborate with NGO and external vendors to set up PAP infrastructure, including PAP SOP, build nationwide network, importation and distribution channel, online platform, physician and pharmacist register and training, problem solving and so on, to provide premium service for patients.

3. Implement Zai Lab patient strategies and monitor projects (incl. plan and budget) to ensure objectives are met and project execution in compliance by working with internal cross-functional team (incl. MKT, sales, Medical, Legal, Compliance, Supply chain, etc.) and external partners/vendors (incl. patients, HCPs, public, NGOs, patient group, etc.).

4. Develop PAP forecast model, support Foundation and external vendors to conduct tax exemption (as needed), clearance and drug inspection, and monitor the inventory of donation goods at both distributor and DTP pharmacy level, to ensure donation supply on time with expected quantity, and in compliant with rules and regulations.

5. Build up relationship with third parties, for example, charity foundation, micro-financing, commercial insurance companies, key medical experts, DTP pharmacies and patient advocacy groups, etc., identify collaboration opportunities and initiate innovative Patient Support Programs, including patient education, patient financial and insurance support, and patient advocacy upon patients’ needs to continually improve patient access.

6. Support central/local Market Access team to achieve local access breakthrough through local and national reimbursement negotiation as needed.

7. Complete other assigned works in time.

Qualifications:

1. Bachelor degree or above, major in pharmaceutical. Clinical medicine or related.

2. At least 2 years’ working experience related to PAP or marketing.

3. Big pharmaceutical company background is a plus.

4. High logicality, result oriented, a good work ethic with strong communication and interpersonal skills.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Scientist,phage display

Discovery
Shanghai

Job Description:

1) Carry out various tasks to support antibody lead selection and optimization.

2) Be capable of multi-task processing and work on various projects in parallel.

3) Execute experiments to generate monoclonal antibodies, including plasmid design and construction, library generation and screening, antibody expression and purification, etc.

4) Communicate with colleagues or CROs to solve project related issues or challenges.

5) Interpret and summarize experimental data.

6) Maintain appropriate experimental records and documentation.

Qualifications:

1) Master in a biological science plus at least 2 years’ industrial experience in antibody discovery.

2) Strong background in molecular biology is required and experiences in phage or yeast display are highly preferred.

3) High accountability, collaborative and proactive attitude with multi-task ability.

4) Excellent attention to detail, strong documentation skills, and ability to communicate effectively.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Scientist,Hybridoma

Discovery
Shanghai

Job Description:

1) Contribute to antibody discovery goals utilizing hybridoma technology for different programs.

2) Participate in project planning activities including immune strategies and screening cascades design.

3) Execute experiments to generate monoclonal antibodies, including mice/rat immunization, serum titer evaluation, hybridoma fusion and culture, screening of antibodies, sucbcloning, hybridoma expansion, cryopreservation, antibody purification and other assignments as required.

4) Be capable of multi-task processing and work on various projects in parallel, and responsible for trouble shooting and delivery task in timely manner.

5) Interpret and summarize experimental data, present results at project meeting.

6) Maintain appropriate experimental records and documentation.

Qualifications:

1) Good experience with antibody generation using hybridoma technology is a must.

2) Strong experience with antibody binding assays, especially ELISA and FACS is required.

3) Experience with transgenic animals, high-throughput automation, molecular biology, hybridoma sequencing and B-cell cloning is a plus.

4) High accountability, collaborative and proactive attitude with multi-task ability.

5) Proven abilit.y to work independently, troubleshoot, interpret and report data.

6) Excellent attention to detail, strong documentation skills, and ability to communicate effectively.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Scientist,Monoclonal Antibody Purification Process

Discovery
Shanghai

Job Description:

1.Lead and participate in the activities include upstream process development, Amber15/Amber250/3L bioreactor/15L bioreactor cell culture process development and DOE experiments.

2.Lead and participate in documents preparing, revising, and management of upstream process development department.

3.Lead and participate in upstream process characterization and validation jobs.

4.Make 15L or 50L bioreactor production according to the manufacturing plan, include documents preparation, material preparation, buffer preparation, process operation, and so on.

5.Upstream process development cooperation, site management and training.

Qualifications:

1)Master degree or Ph.D in biology, pharmacy, etc.

2)3 years+ experience in cell culture process development for monoclonal antibody or bispecifics.

3)Work conscientiously and responsibly, with good professional quality and team spirit.

4)Good listening, speaking, reading and writing skills of English.
If you are interested in this position, please send an email with your resume to talent@zailaboratory.com 

Scientist,Cell Line & Process Development

CMC
Shanghai

Job Description:

1.Lead and participate in the activities include upstream process development, Amber15/Amber250/3L bioreactor/15L bioreactor cell culture process development and DOE experiments.

2.Lead and participate in documents preparing, revising, and management of upstream process development department.

3.Lead and participate in upstream process characterization and validation jobs.

4.Make 15L or 50L bioreactor production according to the manufacturing plan, include documents preparation, material preparation, buffer preparation, process operation, and so on.

5.Upstream process development cooperation, site management and training.

Qualifications:

1)Master degree or Ph.D in biology, pharmacy, etc.

2)3 years+ experience in cell culture process development for monoclonal antibody or bispecifics.

3)Work conscientiously and responsibly, with good professional quality and team spirit.

4)Good listening, speaking, reading and writing skills of English.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Software Engineering (Associate)Manager

IT
Shanghai

Primary Function:

- Response for system architecture, development and code

Major Responsibilities and Duties:

- Response for system technical architecture design, prototype design and function design

- Response for core function development;

- Response for system enhancement development;

- Response for source code quality review and control;

- Response for progress of development project;

- Response for Zai Lab's SLDC system establishment

- According to the company's information security management requirements, comply with all the company's information security policies, processes and perform duties as required to protect the security of the company's information assets

Qualification:

- Bachelor's degree or above in computer related major

- At least 8 years working experience in Software development with C#, Java, pharmaceutical industry experience is a plus.

- Web based thick client's development, designing and coding, testing and troubleshooting.

- Should have strong experience working with Java, .Net, ASP.NET MVC, Web API, C#, Entity Framework, MS SQL Server, MySQL.

- Have strong sense of responsibility, learning ability and execution, solid and good communication ability and service awareness

- Good communication skill and problem-solving oriented, have certain pressure resistance ability

(Sr) IT Engineer –Infrastructure

IT
Shanghai

Primary Function:

- Operation of the servers/network (50%): perform daily operations for requests/changes/incidents on various IaaS/PaaS/SaaS systems, on-premises servers, network devices.

- Operation of the backup/restore, system monitoring (30%): perform daily backup/restore operations for various clients on Cloud/NBU/tape libraries; daily monitoring for server/network/service/security and take actions.

- Implementation of the infrastructure projects (20%): support implementation of infrastructure projects, or application projects as an infra functionary.

Major Responsibilities and Duties:

1) Daily maintenance and support (level 2 or 3) for company's Windows/Linux servers and the modern workplace, including installation, configuration, migration, fault diagnosis, etc.

2) Responsible for cloud setup, configuration operations, maintenance and backup, ensuring that servers are running with highly available.

3) Responsible for monitoring and performance optimization on IT infra environments.

4) Responsible for backup managements on our on-premises servers, workstations and cloud servers.

5) Responsible for management of accounts/permissions/groups/security on AD/AAD/O365 as per requirements.

6) Manage VMware virtualization and Hyper-V system.

7) Support new infrastructure projects in the greater China region.

8) Document all records of server daily operations, backup/restore, monitoring, etc. following by SOPs.

9) Onsite support for end users as level 2 of Service Desk.

10) Other duties as assigned by line manager.

Qualification:

1) Bachelor’s degree or above, major in INFORMATION technology or computer science or other related fields.

2) 2+ years of IT service management and process implementation experience; 2+ years of technical experience on VMware/Hyper-V virtualization; 3+ years of server and network management experience; 1+ years of cloud management experience; 2+ years’ experience in the life sciences company.

3) Good analytical & problem-solving skills with minimal supervision, ability to work on own initiative.

4) Good multitasking skills and abilities Flex with changing priorities.

5) Good written and verbal communication skills. Fluent oral English.

6) MCSE, RHCE, CCNA or relevant certificates are preferred.

 


IT Manager(R&D)

IT
Shanghai

Primary Function:

- Analyzes business requirement to provide necessary solution to Discovery function.

- Solution development in respective function area, manage the operations for all service and system in scope.

Major Responsibilities and Duties:

- Act as primary IT contact in respective function area.

- Identify new system demand by fully understanding business objective, business requirement, standard and regulation.

- Ensure system stability and data integrity.

- take accountability to maintenance high level of customer satisfaction.

- Play a key role on identifying continuous improvement opportunity on responsible function area.

- Provide supporting on validation, testing and installation for assigned function area system.

- Ensure managed system operation aligned with requirement of IT and information security standards.

- Identify root cause of application problem and avoid recurrences.

- Design, develop and provide user training for responsible systems, include maintaining training manuals.

- Build close collaboration with key internal& external stakeholder.

- Perform application administration on assigned system.

- Provide input on demand requirement for creation and maintain IT investment plan.

- Take IT PM role for assigned application implementation project.

Qualification: 

1) Degree in Information Systems or comparable education/ experience

2) Fluent in English (Oral and Written)

3) At least 5 years of experience in pharma R&D area

4) Knowledge on discovery lab or clinical solution IT system.

5) Familiar with R&D application system: ELN, SDMS, LIMS, Argus, Mosaic, CDS, etc.

6) Pro- active, patient, work well in a team environment.

7) able to work independently over customer complain.

8) Willing to learn new technology.

 

Sr IT Business Analyst(focus on Clinical RA PV)

IT
Shanghai
Primary Function:

- Project responsibilities:
  Act as IT PM role for conducting application implementation project including evaluation of capability of vendor, product and service, coordination with vendor and business functions to ensure .

 - Operation responsibilities:

  Act as system manager role for managing security configuration e.g. access control, system configuration e.g. template, business flow, configurable functionality, report generation.

  Handle routine quality activities e.g. change control, deviation, CAPA, computerized system validation and computerized system quality management according to SOPs, guidelines and regulations.

Major Responsibilities and Duties:

1. Act as primary IT contact in respective function area.

2. Identify new system demand by fully understanding business objective, business requirement, standard and regulation.
3. Ensure system stability and data integrity.

4. Take accountability to maintenance high level of customer satisfaction.
5. Play a key role on identifying continuous improvement opportunity on responsible function area.

6. Provide supporting on validation, testing and installation for assigned function area system.

7. Ensure managed system operation aligned with requirement of IT and information security standards.

8. Identify root cause of application problem and avoid recurrences.

9. Design, develop and provide user training for responsible systems, include maintaining training manuals.
10. Build close collaboration with key internal& external stakeholder.

11. Perform application administration on assigned system.

12. Provide input on demand requirement for creation and maintain IT investment plan.

Skills:

- 3+ years of experience working in a pharmaceutical or regulated environment

- Must have experience working on IT Systems in a regulated environment

- Hands-on experience in implementing, management and validation of GxP computerized systems

- Specific system administration experience in clinical, R&D, RA and PV business is preferred,such as CTMS, eTMF, PV, eCTD etc.

- Strong understanding of regulations (NMPA/FDA/EMA) and guidelines(GAMP)

Education:

- Bachelor’s Degree in Computer Science or relevant

- Good spoken and written English skills

Manager,Clinical Pharmacology (Bioanalysis)

Early Development
Shanghai

Job description:

- Collaborate with line management in setting the BA outsourcing strategy and providing the timeline coordination for clinical studies.

- Partner with QA and CP colleagues to identify and qualify the BA CROs, and coordinate CROs in terms of protocol drafting, study monitoring and report delivery to ensure timely and smooth workflow and in the meantime to ensure guidance are met all along.

- Leading the BA team and engage with CROs for trouble-shooting and continuous improvement to deliver against all agreed BA objectives.

- Provide scientific input and represent clinical pharmacology group in project teams, including timely written and oral communication of program related issues to multidisciplinary teams and raise up the solutions from BA perspective.

- Supporting the regulatory inspections or audits for Zai Lab sponsored studies, and address the queries from regulatory agency timely.

- Contribute to a positive and cohesive work environment that fosters teamwork, innovation and professional development.

Basic Requirements:

1) Master or Ph.D. degree or equivalent in a life/biological science or quality-related field, or equivalent combination of education, training and experience.

2) At least 5 years working experience in pharmaceutical industry and demonstrated BA/PK expertise.

3) Thorough understanding of bioanalytical assays, including the PK, ADA and Nab assays. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

4) Excellent interpersonal, leadership & organizational skills to negotiate priorities with stakeholders and help foster a collaborative environment with colleagues across sites and across disciplines.

5) Excellent/accomplished communication skill, facilitation, influencing, and strategic thinking skills within the organization, good at data analysis and presentation.

6) Ability to proactively identify issues, propose solutions and troubleshooting, and work in a team as well as to work independently with limited guidance or supervision

7) Good English (written and spoken) and Chinese

Preferred Requirements:

Relevant to the role, but not critical/essential

- Much experience with regulatory authority inspections

- Experienced for large molecule bioanalysis.

- Experience with clinical pharmacology knowledge.


(Senior) Specialist,Data Management

Medical
Shanghai
Job Descreption:

- Manage / assign responsibilities for Data Managers and also serve as a member of Study Teams. Act as primary Data Management contact and contributor for projects.
- Liaise with CROs, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.

- Create / monitor timelines and ensures that all deadlines are met with quality.

- Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy.

- Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

- Review and provide feedback on protocols, Statistical Analysis Plans, etc.

- Develop and support creation of data management
documentation, specifications and UAT requirements for database and test according to UAT Plan.

- Create, review and revise data management documentation.

- Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements.

- Identify project challenges and risks, and proposing appropriate and strategic solutions to issues.

Qualifications:

- BA or BS degree in a health-related field preferred.

- 0-3 years of related experience in clinical data management in the Pharmaceutical, Biotechnology industry or equivalent.

- Electronic data capture experience (Medidata Rave) and working knowledge of Oncology indications.

- Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials.

- Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management.

- Knowledge of SDTM models and experience transforming raw data into those standards.

- Knowledge of Data Management and Pharmacovigilance processes in clinical trials.

- Knowledge and coding experience using MedDRA and Who Drug dictionaries.

(Associate) Manager,Clinical Ops Process Development

Clinical Operations
Shanghai

Major Responsibilities and Duties:

CTMS and eTMF Management

- Ensure the system set up in consistent to Zai’s internal SOP requirements.

- Specialist to provide support to end users and Administrators.

- Management Q&A of CTMS/eTMF.

- CO internal access and role management.

- Oversight of related system vendor.

CO Internal Process Improvement

- Continuous improvement and troubleshooting of CO internal process.

- Support to develop SOP, WI and/or tool documents to optimize CO process.

- Enable adaption and justification of updated SOP and WI.
Qualifications:

- At least 2 years working experience in clinical trials, CTA, CRA or Project Manager. Previous working with CTMS and/or eTMF system is preferable.

- Excellence communication skill, good in English reading and writing. Interpersonal skill and presenting skill in front of cross function audience is a prior.

- Bachelor degree in medicine, nursing, pharmacology, or pharmaceutical science.

HR Assistant人力资源助理

HR
Shanghai

Job Description:
- Provide admin and operation support to HRVP and HR team, including meeting coordination, reimbursement, event coordination, travel arrangement etc.

- Documents, profile and data preparation and management.

- Other admin and operation work assigned by HRVP and team.
Qualifications:

- Bachelor Degree or above, English Major with Tem 8 is preferred.

- 2 year working experience, biopharma experience is a plus.

- Proactive, responsible, work with strong sense of efficiency, good planning.

- Proven communication skills and good team player.

- Good at thinking and problem solving.

- Knowledge of Office.

- Knowledge of HR is a plus.

SeniorClinical Project Manager

Clinical Operations
Mainland China
Job Description:

1) Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).

2) Leads study team meetings.

3) Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.

4) Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.

5) Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.

6) Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.

7) Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.

8) Provides oversight of CRO performance throughout study implementation.

9) Develops study training and may also coordinate/deliver training, as appropriate.

10) Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.

11) Manages and tracks trial enrollment.

12) Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.

13) Anticipates, manages, and escalates Issues as appropriate.

14) Maintains and archives at trial level documentation.

15) Partners with study team in the management of data locks (final and interim) and site closure.
Qualifications:

1) Bachelor's degree in a scientific or health related field.

2) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, CFDA regulations.

3) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.

4) Excellent verbal and written communication skills.

5) Excellent office computer skills, including experience with clinical databases.

6) Effective cross-functional team player with ability to work in a team environment.

7) Demonstrated leadership skills.

8) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.

9) Experienced in serving on product development teams and understands the product development lifecycle.

AssociateClinical Project Manager

Clinical Operations
Mainland China

Job Description:
1) Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).

2) Leads study team meetings.

3) Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.

4) Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.

5) Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.

6) Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.

7) Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.

8) Provides oversight of CRO performance throughout study implementation.

9) Develops study training and may also coordinate/deliver training, as appropriate.

10) Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.

11) Manages and tracks trial enrollment.

12) Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.

13) Anticipates, manages, and escalates Issues as appropriate.

14) Maintains and archives at trial level documentation.

15) Partners with study team in the management of data locks (final and interim) and site closure.
Qualifications:

1) Bachelor's degree in a scientific or health related field.

2) 5+ years clinical research or relevant experience.

3) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, CFDA regulations.

4) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.

5) Excellent verbal and written communication skills.

6) Excellent office computer skills, including experience with clinical databases.

7) Effective cross-functional team player with ability to work in a team environment.

8) Demonstrated leadership skills.

9) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.

10) Experienced in serving on product development teams and understands the product development lifecycle.

Principal/Senior Biostatistician资深/高级生物统计师

Medical
Shanghai

Primary Function:

The Principal Biostatistician partners with clinical, safety, regulatory, operation, data management, programming, and marketing affairs on clinical development projects, research applications, development science applications, and/or post-marketing requirements. This typically includes partnering with senior scientists independently in the creation of clinical development plans and having primary strategic and operational responsibility for the design, conduct, and evaluation of experiments. For clinical development programs, principal statistician can serve as lead Biostatistics representative on cross-development clinical study teams and project teams

Major Responsibilities and Duties:

1) Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area. Provide statistical leadership for clinical development projects, including working on statistical designs and also providing strategic input into other aspects of clinical development plans and target product profiles.

2) Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to work with cross-functional representatives to work on study planning, study conduct, analyses and reporting.

3) Produce the following study-related deliverables, either personally or by supervising CROs: appropriate sections of study protocols, statistical analysis plans, data monitoring committee charters, data analyses, and sections of clinical study reports and registration documents.

4) Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.

5) Participate in development of standard reporting programs for clinical studies.

6) Participate in development of standard CRFs for clinical data collection.

7) Participate in regulatory submissions including CSR, IND safety update, Annual Report/DSUR, and integrated summaries of safety and efficacy in NDA and BLA.

Qualifications:

1) For Principal:A minimum of 3 years for Ph.D. (6 years for MS) working experience in pharmaceutical and/or Biotech Company and/or related institutes.

For Senior:MSc with a minimum of 3 years working experience in in pharmaceutical and/or Biotech Company, or PhD in statistics, biostatistics, mathematics or similar areas of academic discipline.

2) Good knowledge of theoretical and applied statistics.

3) Good written and interpersonal communication skills with English in a business environment.

4) Proficient in using statistical software, such as R or SAS.

5) Good knowledge of statistical methods in clinical study designs, clinical data analyses. including statistical procedures in analysis software.

6) Advanced Knowledge of statistical analysis methods and results/data presentation formats of clinical data.

7) Good knowledge of regulatory regulations and guidance.

8) Good understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.

9) Must have worked on statistical analysis plans, study protocols and clinical study reports.

10) Preferably, worked on IND or CTA or NDA.

11) Preferably, worked on oncology clinical trials.

12) Ability to exhibit exemplary experimental technique, following procedures with the utmost rigor and attention to detail.

13) Ability to complete complex tasks in a timely manner with a minimal supervision.

14) Highly motivated and able to work well under pressure and shifting priorities independently and as a team member.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Principal Scientist/Associate Director, Translational Medicine

US Discovery
San Francisco Bay Area

Zai Laboratories seeks an innovative leader to drive our translational biology efforts in the areas of cell cycle (CC) and DNA damage response (DDR).  The successful candidate will devise and execute translational strategies to guide indication selection and patient stratification for Zai's late-stage pre-clinical and clinical pipeline in the areas of CC and DDR. This position is located in Menlo Park, CA and reports to the Head of Discovery Biology and Translational Medicine.

Responsibilities:

- Drive translational biology efforts and design and execute biomarker strategies for therapeutic programs targeting the CC and DDR pathways

- Lead translational biology for CC and DDR therapeutics on multi-disciplinary teams for programs in late-stage research (LSR) and in clinical development

- Collaborate with biologists, immunologists, chemists, statisticians, and computational biologists to develop strategies for indication prioritization and patient stratification

- Discovery and validate pharmacodynamic and predictive biomarkers for CC and DDR programs in LSR and in the clinic

- Effectively communicate findings at internal and external meetings through presentations and scientific publications

Qualifications:

- Ph.D. in cellular, molecular biology, or a related field, and 5+ years of experience ideally in an industry setting OR

- MS in cellular, molecular biology, or a related field and 8+ years of experience ideally in an industry setting

- Extensive experience in the discovery and/or development of therapeutics targeting the CC and DDR pathways, as evidenced by a track records of success in advancing drug discovery programs into the clinic

- Translational experience in the discovery and implementation of pharmacodynamic and predictive biomarkers using pre-clinical models, both in vitro and in vivo, and in clinical trials

- Strong track record of multi-tasking and systematically evaluating and prioritizing multiple hypotheses both independently and collaboratively

- Excellent problem-solving and strong communication, data presentation, and visualization skills

- Strong record of scientific accomplishments, as evidenced by publications in top tier journals, patents, and conference presentations

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

Scientist II,Translational Medicine

US Discovery
San Francisco Bay Area
Zai Lab is seeking a Scientist who will join our Translational Medicine group and contribute to building pre-clinical translational hypotheses to guide patient selection and drug combinations with Zai's clinical pipeline. The incumbent will play a role in supporting development of pre-clinical models and biomarker discovery for our clinical pipelines.

This position is located in Menlo Park, CA and reports to our Principal Scientist, Translational Medicine.

Responsibilities:

- Contribute to positioning our cancer therapeutics in right patient selection based on pre-clinical translational hypotheses

- Support development of pre-clinical models and biomarker discovery to establish best patient selection strategy for our clinical trials

- Support Translational Medicine efforts for the large/small molecule pipelines and Zai's clinical assets

- Perform laboratory bench work with minimal supervision and present the results/findings internally and externally

- Perform routine assays (luminescence/fluorescence assay, qPCR, ELISA, cloning, cytotoxicity assay, western blot, immune staining, confocal microscope, gene knockdown/knockout, flow cytometer, cell culture, gene cloning, gene delivery with lenti/retro virus)

- Process human biological samples such as PBMC and perform ADCC, CDC, ADCP assay

- Maintain/update sample/cell database

- Analyze data from experiments and present the data at a meeting

Qualifications:

- PhD in immunology and/or oncology with a minimum of 0-2 years' relevant post-graduate experience in immunology and/or oncology, or MS with a minimum of 8-10 years' experience in immunology and/or oncology

- Broad training/experience in Molecular/Cell Biology including but not limited to cell culture, DNA/RNA extraction, PCR/qPCR, ELISA, confocal microscope, cloning, and primary cell isolation/culture, immune cell differentiation/activation/co-culture is required

- Experience in the field of immunology and/or oncology is required, including hands-on experience with functional characterization of large/small molecules in vitro/ex vivo

- Proficiency in multi-color flow cytometer is required

- Experience in a live cell imaging using florescence/confocal microscope is a huge plus

- Experience with human biological samples such as PBMC to perform ADCC, CDC, ADCP assay is a huge plus

- Knowledge of tumor microenvironment, immune-oncology, human immunology, in vivo animal model, biomarker, RNAseq, histology, immunohistochemistry is highly desirable

- Demonstrated success in designing, conducting, and analyzing data with minimal supervision, as evidenced by a robust track record of productivity with publications in top-tier journals

- Strong communication and collaboration skills, and capability to conduct research in fast-paced, cross-functional team environment

- Ability to interpret data clearly and concisely both verbally and visually in presentations

- High integrity and desire to discover and develop transformational medicines for patients

- Strong interpersonal ability to collaboratively work in a cross-functional team setting

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

Principle Scientist,Medicinal Chemistry

US Discovery
San Francisco Bay Area

Zai Lab is seeking a skilled Medicinal Chemist to drive small molecule discovery projects on oncology targets, from project evaluation, developing and implementing chemistry strategy for hit identification and lead optimization through to selection of preclinical development candidate. The successful candidate will be a member of a fast-paced and interactive research team contributing to the discovery and development of novel therapeutics. 

Organizational Relationships:

The Principal Scientist reports to the Head of Medicinal Chemistry, and collaborates extensively with DMPK, in vitro Biology and in vivo Pharmacology teams. He or She will oversee outsourced activities and manage internal resources.

Responsibilities:

- Initiate and drive chemistry of one or more small molecule drug discovery projects. Apply a wide variety of drug design concepts, and organic and medicinal chemistry skills in the design and synthesis of novel molecules as potential drug candidates

- Assist in choosing new biological targets and contribute to overall corporate medicinal chemistry strategy

- Closely follow emerging results of biological testing, ADME characterization, and other lead profiling assays; Proactively propose new strategies to improve key attributes and work collaboratively with cross-functional project team to overcome project hurdles. Drive SAR optimization cycle to achieve project goals.

- Coach junior chemists. Provide supervision and guidance to direct reports

- Manage external chemistry resources by setting up direction and priorities, as well as by monitoring progress, quality and timeline

- Proactively seek out new information in the literature and incorporate into individual project(s) as well as the overall program

- Be responsible for inventory upkeep, data tracking and archiving, and supply ordering

- Participate in intellectual property analysis and contribute to patent generation and application preparation

- Communicate effectively within project teams. Present chemistry strategy, plan and progress at project team meetings.

- Contribute to fostering a culture that embraces continuous learning and improvement and open communication; take a proactive role in scientific development and personal growth

Qualifications:

- Ph.D. in organic or medicinal chemistry and a minimum of 5-10 years' experience, or MS with 8-10 years' relevant experience in a high-performing biotech or pharma with solid knowledge of modern synthetic methodology

- Demonstrated success in lead identification and lead optimization, delivering multiple novel molecules into preclinical and clinical development. Solid experience in structure-based drug design

- Project leadership experience driving team through lead optimization and selection of development candidate

- Solid understanding of various scientific disciplines in addition to medicinal chemistry, including biochemistry, DMPK, and toxicology.

- Knowledgeable about molecular attributes that can enhance success in early development and beyond

- Demonstrated ability to resolve key scientific hurdles by effectively utilizing available information and technical expertise

- Strong track record of productivity, as evidenced by driving project forward and robust publications and patents

- Excellent written and oral communication skills; ability to present chemistry strategies and progress to internal team, and to communicate effectively with external partners.

- Strong team spirit and interpersonal skills. Ability to work collaboratively in a cross-functional team setting, as well as with CROs and external partners.

- Desire and initiative to learn and tackle new challenges. Highly motivated and flexible with ability to work in fast-paced, goal-driven environment.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

Research Associate/Senior Research Associate- Translational Medicine

US Discovery
San Francisco Bay Area

We are seeking a Research Associate/Sr. Research Associate to join our Translational Medicine group and contribute to building pre-clinical translational hypotheses to guide patient selection and drug combinations with Zai's clinical pipeline. The incumbent will play a role in supporting development of pre-clinical models and biomarker discovery for our clinical pipelines.

This position reports to our Principal Scientist, Translational Medicine.

Responsibilities:

- Contribute to positioning our cancer therapeutics in right patient selection based on pre-clinical translational hypotheses

- Support development of pre-clinical models and biomarker discovery to establish best patient selection strategy for our clinical trials

- Support Translational Medicine efforts for the large/small molecule pipelines and Zai's clinical assets

- Perform routine assays (luminescence/fluorescence assay, qPCR, ELISA, cloning, cytotoxicity assay, western blot, immune staining, confocal microscope, gene knockdown/knockout, flow cytometer, cell culture)

- Process human biological samples

- Maintain/update sample/cell database

- Analyze data from experiments and present the data at a meeting

Requirements:

- BS in a scientific discipline and a minimum of 2-5 years' related laboratory experience, or MS with 0-2 years' experience

- Broad training/experience in   Molecular/Cell Biology including but not limited to cell culture, DNA/RNA extraction, PCR/qPCR, ELISA, and primary cell isolation/culture is required

- Experience in the field of tumor biology is highly desirable, including hands-on experience with functional characterization of large/small molecules in vitro/ex vivo

- Experience in immunology/immune oncology is a huge plus

- Experience with human biological samples such as PBMC and in multi-color flow cytometer for characterization of human immune cells is preferred

- Demonstrated success in designing, conducting, and analyzing data with minimal supervision, as evidenced by a robust track record of productivity by advancing therapeutic programs

- Strong communication and collaboration skills, and capability to conduct research in fast-paced, cross-functional team environment

- Ability to interpret data clearlyand concisely both verbally and visually in presentations

- Ability to handle multiple tasks

- High integrity and desire to discover and develop transformational medicines for patients

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com.

 

TTFields Sales Executive肿瘤电场治疗销售代表

TTField Business Unit (HK)
Hong Kong

Job Overview

We are looking for a competitive pharmaceutical sales representative who can thrive in a fast-paced business environment. The pharmacy sales rep will act as the key link between our company and healthcare professionals and you will aim at meeting sales targets.

Responsibilities and Duties

-  Promote key products to current and potential clients in HA & private Sectors

-  Achieve product and company sales targets and business objectives

-  Establish and implement sales plans according to overall sales and marketing strategies

-  Identify opportunities for new business

-  Develop and maintain rapport relationships with KOLs and key accounts, with clear prioritization and focus

-  Support new product launches and other PR / marketing programs and activities 

-  Effectively utilize sales tools and provide high quality in-service / product demo to familiarize customer product usage

-  Perform case follow-up

-  Gather market intelligence and feedback on a regular basis

-  Ensure adherence to company policies, procedures and business ethics

-  Perform ad hoc projects as required

Qualifications

-  University graduate, preferably degree holder in science related discipline

-  At least 5 years of sales experience in pharmaceutical or healthcare industry, with 2 years in Oncology field is   highly preferred

-  Outgoing, patient and friendly character with strong communication and problem-solving skills

-  Fluent Cantonese & good English

-  Good team player

-  Proactive, motivated and committed self-starter

-  Proven sales track record

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Medical Affairs Manager / Associate Manager医学事务经理/副经理

Medical Affairs
Hong Kong

Job Overview

Works with team head to execute medical affairs strategies and complete medical affairs projects cope with our upcoming pipeline launches.  Focus of responsibilities can be on any part of the product lifecycle from research through the on-market phase. Activities can include development of key medical and research contacts across a variety of disease state areas, development and implementation of clinical study protocols, development and execution of clinical studies, medical input/support for product development, medical support for customer inquiries and medical assessment of on market product issues. Must be able to review, synthesize data clearly and present conclusions to medical directors. Will need to be able to work independently, within an internal cross functional team and with external partners.

Responsibilities and Duties

KOL Management & Medical Support:

1. Contributes to mapping / profiling of KOLs/decision makers in line with segmentation.

2. Develop professional relationships, with KOLs/decision makers.

3. Collect, analyze and report insights that may impact Zai Lab development plans /trial designs.

4. Provide and discuss scientific information and data to healthcare professionals to ensure quality and accuracy of medical and scientific information on new treatment options including Zai Lab products and selected areas of therapeutic interest.

5. Liaise and provide up-to-date medical support to relevant external groups to facilitate listing of products in medical guidelines, formularies to impact pricing and health-economic discussions.

6. Provide speaker training to health care professionals to support the best use of new therapies developed and commercialized by Zai Lab.

7. Compliance: Ensure products are all comply with all applicable laws and local/global safety responsibilities

8. Assist the Corporate Communication in handling media issues & enquiries, particularly those medically related.

9. Assist and enhance the generation of high quality, impactful publications and collateral material that conform to the appropriate standards and regulations

10. Support implementation of pre-launch studies for PI and site selection.

Clinical Development Support:

1. Contribute to the identification of appropriate clinical investigators and facilitates placement into Zai Lab sponsored clinical trials.

2. Support the investigational sites, as needed, as part of a cross-functional team with Clinical Operation and the Medical Advisor and others as appropriate.

3. Identify clinical investigators with research proposals that are consistent with our product development strategies and facilitate the Investigator-Initiated Trials (IIT) process including study completion, presentation, and publication, as appropriate.

4. Support the investigators to comply with the IIT process in accordance with the guidelines, providing knowledge and guidance for legal and financial local regulations, as appropriate.

Information Management/Insights:

1. Collaborate with Zai Lab colleagues to actively support medical and scientific meetings by collecting and interpreting insights /presentations/ results.

2. Evaluate the impact of competitive information to share internally and externally as post-meeting deliverables.

Internal Support:

1. Provide medical support and training (i.e. disease state and product) to Zai Lab colleagues (e.g. sales reps, CRAs, etc.).

2. Screen business opportunities.

3. Serve as a resource for projects and collaborate with internal colleagues.

4. Collaborate with Medical Teams and other cross-functional groups (i.e. Business Franchise Teams, Market Access).

Qualifications

1. University graduate in medical science, pharmacy, pharmacology or related discipline.

2. At least 3 years' experience in medical affairs in pharmaceutical industry.

3. Knowledgeable of regulatory and compliance regulations and guidelines relevant to the industry

4. Prior experience establishing and maintaining long term relationships with customers and key thought leaders through scientific engagement

5. Experience to delivering effective, high quality scientific presentations and communicate scientific data to both internal and external customers

6. Ability to work in a fast paced and dynamic environment

7. Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.

8. Strong communication and presentation skills

9. Self-starter

    a)  Driven to perform

    b)  Self-directed: needs little explicit direction

10. Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Senior Manager, Medical Information高级经理,医学信息

Medical Affairs
Shanghai

Major Responsibilities and Duties:

1.Working with team to contribute for professional information strategy development.

2.Making alignment of professional information strategy, plans and activities within organizations.

3.Be responsible for budget tracking and reporting to the relevant MI issues. Monitor timeline and manage project to conclusion and implementation.

4.Provide medical information and literature search for KOLs, HCPs and internal customers, analysis literature request to provide insight for medical and business plan.

5.Competitive Intelligence surveillance, analysis and timely report, provide CI information for medical and business decision and plan.

6.Lead digital medical service for internal and external customers.Any other responsibilities and duties which may be required from time to time.

Qualifications:

1.Bachelor and above degree. Academic background with a medical related degree is preferred.

2.5+ yrs working experience on medicine, pharmacy or pharmaceutical industries.

3.Familiar with the medical information work.

4.Good time management.

5.Good collaborative skills.

6.Good computer using skills.Fluency in both written & spoken English.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

(Senior) Marketing Manager(高级)市场经理

ONCO Marketing
Shanghai

Primary Function:

As a key person in Central Marketing Function, you will be working on the analysis on central market for the business potential and opportunity by central level. Accordingly, you will develop Optune marketing plan and effectively communicate with KOLs and sales team to make sure it is appropriate to the market. Besides, you will be executing on marketing activities like VIP events and any other society congress with good budget control with the developing and maintaining of Optune KOLs and speakers.

Major Responsibilities and Duties:

1.Support OPTUNE Launch Lead in developing and executing pre-launch and launch strategies and plan execution for the GBM Neurosurgery/Radiation/Oncology Department.

2.Use a broad set of channels (e.g. surveys, field visits, KOL relationships) to gather deep customer insights to gain holistic understanding of the patient journey and what motivates and drivers customer behavior.

3.Develop brand strategy including positioning & marketing messages and communication materials that are consistent with the product positioning and product strategy.

4.Develop creative product/brand campaigns/GBM neurosurgery platforms reinforcing the positioning and SoV.

5.Understand and track national KOLs’ opinions and develop neurosurgery department advocates for TTF treatment.Collaborate with sales team to deliver the sales revenue align with the budget.

Qualifications:

1.Bachelor degree or above on pharmaceutical, clinical medicine or clinical medicine related with outstanding English.
2.At least 5 years working experience in pharmaceutical company with marketing GBM related area is preferred.

3.At least 3 years in TA of ONCO or specific drug.

4.Marketing experiences with top 10 pharmaceutical company would be highly preferred.

5.Excellent market analytical & problems’ solving skills with Strong planning skill.

6.High logicality with quick learning capabilities and a good work ethic with strong communication and interpersonal skills.Capability to work under pressure & perform duties with high quality timely.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com