Associate Director, Biosample Operations Management

$185,000 - $215,000/Yr

Zai Lab - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

Professional, Scientific, and Technical Services

About the position

The Associate Director, Biosample Operations Management (AD, BOM) at Zai Lab is responsible for overseeing the planning and execution of biological sample collection and biomarker strategies for the company's clinical development pipeline. This leadership role requires strong problem-solving skills and the ability to work both independently and collaboratively, ensuring the implementation of clinical biomarker and diagnostic plans across various therapeutic areas.

Responsibilities

• Plan and execute biological sample collection and biomarker strategies for clinical programs.
• Establish operational objectives, policies, procedures, and work plans.
• Define strategic timelines and allocate resources for the biosample operations team.
• Oversee budget management to support biosample operations effectively.
• Ensure data consistency with collection and assay plans in collaboration with Translation Medicine and Data Management teams.
• Review clinical study protocols for feasibility of biological sampling and alignment with company policies.
• Utilize project management skills to address complex issues and ensure deliverables are met.
• Maintain oversight of all study biosample operational activities and report on status across programs.
• Monitor investigator site sample handling training and quality of samples received, recommending corrective actions as necessary.
• Ensure study adherence to ICH/GCP and SOPs.
• Identify areas for best practices and process improvements.

Requirements

• Bachelor's degree in a scientific or health-related discipline.
• 10 years of relevant experience, with 8 years in a clinical research setting or pharmaceutical/biotechnology R&D environment.
• Five years of biosample management experience preferred.
• In-depth knowledge of biosample management principles and practices.
• Extensive clinical development experience, particularly in oncology and/or immuno-oncology.
• Successful track record in oncology employing various biomarker endpoints from tissue and blood samples.
• Advanced critical reasoning skills for problem identification and resolution.
• Detail-oriented with strong organizational and time management skills.
• Exceptional verbal and written communication skills.

Nice-to-haves

• Experience with genomic biomarker endpoints including NGS and PBMC-based analysis.
• Proven ability to lead projects and influence stakeholders in complex situations.

Benefits

• Health insurance
• Paid time off
• Parental leave
• 401(k) matching