Director, Clinical Operations – Biotech
San Francisco, CA or Boston, MA
We are seeking a Director of Clinical Operations to lead and drive the execution of clinical trials for an innovative biotech company. This role is ideal for a highly experienced clinical operations professional with a strong background in managing Phase I-III trials.
Key Responsibilities
- Lead the planning, execution, and oversight of global clinical trials across multiple therapeutic areas.
- Ensure compliance with GCP, ICH guidelines, and regulatory requirements while maintaining high-quality standards.
- Oversee CRO and vendor management, ensuring timelines, budgets, and deliverables are met.
- Develop and implement clinical trial strategies, SOPs, and best practices to optimize operational efficiency.
- Collaborate with cross-functional teams, including clinical development, regulatory, and medical affairs.
- Provide leadership and mentorship to the clinical operations team, fostering growth and development.
- Contribute to regulatory submissions (IND, NDA, BLA) and support interactions with health authorities.
- Identify and mitigate operational risks, proactively solving challenges in trial execution.
Qualifications
- 8+ years of clinical operations experience in biotech/pharma, with proven leadership experience.
- Strong expertise in managing Phase I-III clinical trials, ideally in oncology, rare diseases, or immunology.
- Experience overseeing CROs, vendors, budgets, and trial timelines.
- In-depth understanding of FDA, EMA, and global regulatory requirements.
- Strong leadership, problem-solving, and cross-functional collaboration skills.
- Ability to thrive in a fast-paced, high-growth biotech environment.
- Bachelor’s degree required; advanced degree preferred (MS, MPH, PharmD, or equivalent).