Associate Director, Biosample Operations Management

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on discovering, developing and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience , and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.

Zai Lab has its U.S. headquarters in Cambridge, Mass. and R&D functions in the San Francisco Bay Area and San Diego, where its U.S.-based clinical development and clinical operations teams reside. Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad late-stage pipeline of innovative drug candidates. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has seven approved products in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. 

The Associate Director, Biosample Operations Management (AD, BOM) is responsible for the planning and execution of biological sample collection (Biomarker/CDx, PK, PD, ADA), translational, and biomarker strategies for Zai’s rapidly growing pipeline of small and large molecules in early- through late-stage clinical development. This role establishes operational objectives, policies, procedures, and work plans. This leadership position requires an innovative thinker with strong problem-solving skills and the ability to work both independently and collaboratively. This role is based in our South San Francisco, CA office.

• Ensure the implementation and execution of the clinical biomarker and diagnostic plans for clinical programs in early- and late-stage clinical development across therapeutic areas.
• Define strategic timelines, allocate essential resources, and oversee budget management to support the biosample operations team effectively.
• Accountable for ensuring that data received is consistent with the collection and assay plans and protocol in conjunction with Translation Medicine and Data Management teams.
• Review the clinical study protocol and ICF 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; supports the team in problem solving complex issues.
• Maintain oversight of all study biosample operational activities and regularly report on status across the portfolio of programs/studies.
• 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.
• Support the development of infrastructure to support the organization, including objectives, policies, procedures, and work plans. 
   

REQUIRED:

• Bachelor’s degree in a scientific or health-related discipline with 10 years relevant experience of which 8 years are in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment. 

PREFERRED:

• Five years of biosample management experience. 
• In-depth knowledge and understanding of biosample management, principles, practices, processing, and analysis.
• 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.
• Advanced critical reasoning skills, including the identification and resolution of a wide range of complex problems.
• Detail-oriented with the ability to work independently, manage competing priorities, and adapt to new situations.
• Excellent planning, organizational, and time management skills.
• Proven ability to achieve results and build effective working relationships within a multi-cultural and geographically diverse team.
• Exceptional verbal and written communication and presentation skills, with the ability to effectively convey key messages and independently engage with teams and stakeholders.
• Proven ability to lead projects and persuade/influence leaders and peers in sensitive complex situations.
• Competent in the application of standard business procedures (standard operating procedures (SOPs), International Conference on Harmonization (ICH), Global Regulations, Ethics, and Compliance).
• Ability to work across several time zones.
• Must have the highest personal values and ethical standards.

The pay range for this position at commencement of employment is expected to be between $185K and $215K/year. Base pay offered may vary depending on multiple individualized factors, including location, job-related knowledge, skills, education and experience. The total compensation package for this position may also include other elements, including corporate bonus and equity awards.  In addition Zai Lab offers a robust benefits package which includes comprehensive health insurance, 401(k) with company match, family advocacy programs, and various paid time off benefits, such as vacation, sick time, and parental leave. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary as well as any other discretionary payment and benefits at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.