Title: Clinical Development Executive Director
Reports to: EVP
Location: Bay Area
Salary Range: 280K-320K
Company Overview
This is a biopharmaceutical company specializing in the development of novel therapies aimed at treating cancers. We are recruiting a seasoned drug development leader to join the team as the Executive Director of Clinical Development. This is a company aiming to be a leader in the RAS-targeted oncology field and the person hired will be overseeing the clinical-stage activity for RMC molecules in clinical development. In this strategic role, you will be instrumental in shaping clinical development plans, leading programs from early-stage studies through regulatory approval and potential commercialization.
- Develop and execute clinical development strategies for company pipeline, aligning scientific, regulatory, and commercial goals.
- Lead and mentor a cross-functional clinical development team, fostering a culture of collaboration, innovation, and excellence.
- Oversee all aspects of clinical trial operations, including design, site selection, patient recruitment, data analysis, and regulatory compliance.
- Build and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.
- Analyze and interpret clinical data, providing strategic insights to guide program development and inform decision-making.
- Manage clinical development timelines, ensuring efficient resource use and milestone achievement.
- Stay updated on the latest scientific advancements and regulatory trends to maintain industry leadership.
- Collaborate with cross-functional teams, including research, regulatory, commercial, and finance, to ensure seamless program execution.
- Manage multiple direct reports and lead a team of managers.
- Advanced degree (MD, PhD, or equivalent) in a biomedical field with 8+ years of experience in the pharmaceutical/biotech industry.
- Extensive experience in data analysis, interpretation, and clinical relevance in the biotech/pharma sector.
- Proven success in designing and conducting clinical trials across multiple phases, with direct experience in Phase 1 drug development.
- Strong track record in developing clinical strategies and advancing them through governance.
- Deep understanding of GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.).
- Proven experience guiding drug development through interactions with health authorities (e.g., FDA, EMA).
Preferred Skills:
- Experience enhancing processes, systems, and tools within the pharmaceutical/biotech industry.
- Proven ability to create clinical strategies leading to label-enabling outcomes and commercialization.
- Experience with NDA/BLA/MAA submissions to global health authorities is a significant advantage.
