VP/Head of Clinical Operations
Location: California (SF Bay Area) or Singapore
Full Time
Engine Biosciences is seeking a highly experienced and strategic Head of Clinical Operations to lead and oversee the execution of clinical trials for our novel oncology therapeutics. This key leadership role will be responsible for ensuring efficient, high-quality, and regulatory-compliant clinical operations from study intitiation to completion. The ideal candidate will have deep expertise in managing global clinical trials, working with CROs, and optimizing clinical operations processes in a fast-paced biotech environment.
Responsibillities
- Develop and implement clinical operations strategies to support the successful execution of clinical trials, ensuring alignment with corporate objectives.
- Oversee end-to-end clinical trial operations, including site selection, patient recruitment, study monitoring, data management, and trial execution.
- Lead interactions with CROs, vendors, and investigators to ensure timelines, budgets, and quality standards are met, including managing contract negotiations and performance oversight.
- Collaborate closely with clinical development, regulatory, and translational science teams to align operational plans with clinical strategies, regulatory submissions, and corporate objectives.
- Ensure compliance with global regulatory requirements, GCP guidelines, and company SOPs.
- Identify and mitigate risks associated with clinical trials, proactively addressing challenges to keep programs on track.
- Drive continuous improvement in clinical operations, implementing best practices and innovative solutions to enhance trial efficiency and effectiveness.
- Build and lead a high-performing clinical operations team, fostering a culture of collaboration, accountability, and excellence.
- Develop and manage clinical trial budgets, ensuring cost-effective execution and proactive financial risk mitigation, working with clinical development and finance teams.
- Support financing and business development activities by representing the clinical operations function with investors and companies.
Qualifications and Experience
- Master’s or advanced degree in life sciences, or a related field.
- 10+ years of experience in clinical operations within the biotech or pharmaceutical industry, with a strong focus on oncology.
- Proven track record of managing global clinical trials, from Phase 1 through late-stage development.
- Expertise in vendor and CRO management, contract negotiations, budgeting, and clinical trial execution best practices.
- Strong leadership and team management skills, with a hands-on approach and the ability to drive cross-functional collaboration.
- Deep knowledge of regulatory requirements (FDA, EMA, ICH GCP) and experience with regulatory agency interactions and inspections.
- Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.