Executive Director, Clinical Development
$265,000–$331,000 year
HybridRedwood City, California, United States
Redwood City, California, United StatesHybridFull Time$265,000–$331,000 yearSenior LevelDoctorate Or Professional DegreeSmall
Full TimeSenior LevelDoctorate Or Professional DegreeSmall
Job Summary
Develop strategic plans and execute clinical development programs for Revolution Medicines' clinical-stage molecules from early-stage studies through regulatory submissions. Lead a high-performing cross-functional team, overseeing trial design, site selection, patient recruitment, and regulatory compliance while managing multiple direct reports. Provide critical insights on clinical data to inform program decisions and establish relationships with clinical investigators and health authorities. Manage development timelines, budgets, and milestones to drive transformative therapies for patients with RAS-addicted cancers.
Required Qualifications
- MD, PhD or similar advanced biomedical graduate degree
- 13+ or more years experience in pharmaceutical/biotech industry or academic background at the level of Associate Professor or higher
- Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry
- Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage
- Direct experience with Phase 1 drug development
- Experience authoring and clinical development strategy(ies) and bringing forward for governance
- Extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations
- Proven experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others)
- Has led Health Authority interaction(s)
- Outstanding written and business presentation skills
- Experience publishing results of a clinical trial in a peer-reviewed journal
Desired Qualifications
- Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry
- Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization
- Experience submitting an NDA/BLA/MAA to global health authorities
- Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation
- Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc
- Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs
- Direct experience with Phase IV drug development
- Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making
- Has demonstrated the ability to serve as a company spokesperson both internally and externally
- Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc - resulting in demonstrable outcomes (e.g. new study proposals or new disease indications)
- Has demonstrated courage and conviction in past positions and responsibilities
- Skilled in conflict resolution
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