Zai Lab
Associate Director, Clinical Operations - Oncology (Compound Lead) (Office Based
Zai Lab, South San Francisco, California, us, 94083
Associate Director, Clinical Operations - Oncology (Compound Lead) (Office Based 3X/wk)
Associate Director, Clinical Operations will provide strategic leadership and oversight for the planning, execution, and delivery of global clinical trials from study start‑up through close‑out.
The role is accountable for ensuring clinical programs are executed in alignment with corporate goals, regulatory requirements (ICH‑GCP and local regulations), and industry best practices.
Responsibilities
Lead the operational strategy and execution of one or more global clinical trials, ensuring alignment with corporate objectives and regulatory standards.
Own the end‑to‑end delivery of assigned clinical trials, including country and site selection, site start‑up, contracting, patient recruitment, and retention strategies, ensuring timelines, budgets, and quality metrics are met.
Drive cross‑functional collaboration to develop and finalize critical clinical trial documents and systems, including protocols, informed consent forms (ICFs), budget templates, EDC, IxRS, central/specialty labs, ECG, imaging, PRO specifications, drug supply logistics, biomarker/sample management plans, TMF, and CSRs.
Develop and implement comprehensive study plans encompassing vendor oversight, risk management, quality assurance, safety monitoring, communication strategies, trial monitoring, and TMF management.
Ensure timely creation, maintenance, and quality control (QC) of the Trial Master File (TMF) in compliance with regulatory and internal standards.
Provide oversight and support for clinical systems including EDC, IxRS, and CTMS, ensuring data accuracy and operational efficiency.
Monitor and manage study budgets, timelines, and milestones; proactively identify risks and implement mitigation strategies.
Lead financial oversight of assigned studies, including vendor budget management, variance analysis, and resolution planning.
Drive global vendor selection and management, including participation in the RFP process and contract negotiations.
Oversee outsourced activities to ensure CRO and vendor performance aligns with contractual obligations and quality expectations.
Lead the planning and execution of investigator meetings in collaboration with cross‑functional teams.
Maintain up‑to‑date knowledge of relevant therapeutic areas and evolving clinical research practices to inform operational strategies.
Ensure full compliance with ICH‑GCP, regulatory requirements, and company SOPs across all assigned studies.
Work across several time zones.
Qualifications Required
Undergraduate degree in a scientific or health‑related discipline with 10 years relevant experience of which 8 years are clinical experience in the pharmaceutical industry, including 5 years in study management experience; or equivalent combination of education, training, and experience.
Preferred
Proven experience in leading global clinical trials with prior people management responsibilities.
Strong command of clinical trial processes, international regulatory requirements, and ICH‑GCP guidelines.
Demonstrated expertise in project and program management, including risk assessment, timeline and budget oversight, and contingency planning.
Skilled in vendor management and fostering strong, customer‑focused relationships with investigators, peers, and external partners.
Excellent communication skills—both verbal and written—with the ability to convey key messages, resolve conflicts, and influence cross‑functional teams.
Effective leadership and collaboration skills with a track record of building trust and managing global teams.
Highly organized with strong planning and prioritization capabilities.
Maintains the highest standards of integrity and ethics.
Additional Information Pay Range:
$191,000 – $212,000 per year (variable based on location, role, experience, and other factors).
Benefits:
Comprehensive health insurance, 401(k) with company match, family advocacy programs, and paid time off including vacation, sick time, and parental leave. Details of participation will be provided upon offer.
Employment:
At‑will position; the company reserves the right to modify base salary and benefits at any time.
EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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The role is accountable for ensuring clinical programs are executed in alignment with corporate goals, regulatory requirements (ICH‑GCP and local regulations), and industry best practices.
Responsibilities
Lead the operational strategy and execution of one or more global clinical trials, ensuring alignment with corporate objectives and regulatory standards.
Own the end‑to‑end delivery of assigned clinical trials, including country and site selection, site start‑up, contracting, patient recruitment, and retention strategies, ensuring timelines, budgets, and quality metrics are met.
Drive cross‑functional collaboration to develop and finalize critical clinical trial documents and systems, including protocols, informed consent forms (ICFs), budget templates, EDC, IxRS, central/specialty labs, ECG, imaging, PRO specifications, drug supply logistics, biomarker/sample management plans, TMF, and CSRs.
Develop and implement comprehensive study plans encompassing vendor oversight, risk management, quality assurance, safety monitoring, communication strategies, trial monitoring, and TMF management.
Ensure timely creation, maintenance, and quality control (QC) of the Trial Master File (TMF) in compliance with regulatory and internal standards.
Provide oversight and support for clinical systems including EDC, IxRS, and CTMS, ensuring data accuracy and operational efficiency.
Monitor and manage study budgets, timelines, and milestones; proactively identify risks and implement mitigation strategies.
Lead financial oversight of assigned studies, including vendor budget management, variance analysis, and resolution planning.
Drive global vendor selection and management, including participation in the RFP process and contract negotiations.
Oversee outsourced activities to ensure CRO and vendor performance aligns with contractual obligations and quality expectations.
Lead the planning and execution of investigator meetings in collaboration with cross‑functional teams.
Maintain up‑to‑date knowledge of relevant therapeutic areas and evolving clinical research practices to inform operational strategies.
Ensure full compliance with ICH‑GCP, regulatory requirements, and company SOPs across all assigned studies.
Work across several time zones.
Qualifications Required
Undergraduate degree in a scientific or health‑related discipline with 10 years relevant experience of which 8 years are clinical experience in the pharmaceutical industry, including 5 years in study management experience; or equivalent combination of education, training, and experience.
Preferred
Proven experience in leading global clinical trials with prior people management responsibilities.
Strong command of clinical trial processes, international regulatory requirements, and ICH‑GCP guidelines.
Demonstrated expertise in project and program management, including risk assessment, timeline and budget oversight, and contingency planning.
Skilled in vendor management and fostering strong, customer‑focused relationships with investigators, peers, and external partners.
Excellent communication skills—both verbal and written—with the ability to convey key messages, resolve conflicts, and influence cross‑functional teams.
Effective leadership and collaboration skills with a track record of building trust and managing global teams.
Highly organized with strong planning and prioritization capabilities.
Maintains the highest standards of integrity and ethics.
Additional Information Pay Range:
$191,000 – $212,000 per year (variable based on location, role, experience, and other factors).
Benefits:
Comprehensive health insurance, 401(k) with company match, family advocacy programs, and paid time off including vacation, sick time, and parental leave. Details of participation will be provided upon offer.
Employment:
At‑will position; the company reserves the right to modify base salary and benefits at any time.
EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or disability.
#J-18808-Ljbffr