Associate Director, Clinical Operations - Oncology (Compound Lead)

The 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. This role is accountable for ensuring that clinical programs are executed in alignment with corporate goals regulatory requirements (ICH-GCP and local regulations) and industry best practices. The Associate Director will lead cross-functional teams manage external partners (e.g. CROs vendors) and drive operational excellence across multiple studies or programs. This position plays a critical role in risk management resource planning and ensuring that timelines budgets and quality standards are consistently met. This role is based in our South San Francisco CA office.

• 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 Request for Proposal (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 skillsboth verbal and writtenwith 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 :

The pay range for this position at commencement of employment is expected to be between $191K and $212K/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. Thats 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.