Associate Director, Clinical Development

Revolution Medicines•Redwood City, CA

10h•Hybrid

About The Position

We are seeking an experienced clinical scientist to serve as Associate Director, Clinical Science in support of Revolution Medicines’ late-stage clinical programs. In this role, you will independently lead defined clinical science workstreams within pivotal and supportive studies and support execution of the registrational clinical development strategy for assigned molecule(s) and indication(s). The Associate Director plays a critical role in ensuring high-quality clinical data review, protocol consistency, and submission-readiness for late-stage programs. This position operates with substantial autonomy within assigned scope and collaborates closely with more senior clinical science team members and the study Medical Director to ensure medically sound and regulatory-aligned execution. Furthermore: Independently lead defined clinical science workstreams within pivotal and registration-enabling studies (e.g., endpoint strategy, data review oversight, CSR section ownership, data consistency initiatives). Contribute substantially to protocol development, CRF design, ICF updates, and alignment of data standards with downstream regulatory requirements. Drive ongoing clinical data review activities, including plausibility review, query trend analysis, and preparation for database lock. Accountable for assigned clinical science deliverables supporting regulatory submissions, including CSR sections, briefing package content, and health authority response inputs. Support preparation of regulatory documentation and responses to health authority questions. Collaborate closely with Biostatistics, Data Management, Medical Writing, Medical Directors, Pharmacovigilance, and Clinical Operations to ensure alignment and submission readiness. Participate in study team meetings and represent Clinical Science in sub-team discussions. May serve as Clinical Science lead for smaller or supportive studies, based on experience and study complexity. Mentor Senior Clinical Scientists and Clinical Scientists as appropriate. Proactively identify risks, propose mitigation strategies, and escalate significant issues as appropriate to Directors or Senior Directors. Contribute to cross-functional discussions to support eSective and eSicient study execution.

Requirements

Bachelor’s Degree (life sciences preferred); Advanced Clinical/Science Degree is a plus (e.g., PharmD, PhD, MSN, MPH, etc.).
5+ years of clinical development or relevant experience within a pharmaceutical, biotech, or academic clinical research setting; late-stage development experience preferred.
Demonstrated experience contributing to pivotal or registration-enabling studies.
Strong knowledge of GCP, ICH, FDA, EMA, and other relevant regulatory guidelines.
Experience contributing to protocol development, CRF design, and regulatory documentation.
Strong analytical skills and experience interpreting clinical trial data.
Proven ability to work eSectively in cross-functional teams and integrate multiple perspectives.
Excellent written and verbal communication skills.
Strong organizational skills and ability to manage multiple deliverables.

Nice To Haves

Experience contributing to NDA/BLA/MAA submission components.
Experience supporting health authority interactions.
Demonstrated ability to lead defined study-level initiatives.
Experience mentoring junior clinical science staffs.

Responsibilities

Independently lead defined clinical science workstreams within pivotal and registration-enabling studies (e.g., endpoint strategy, data review oversight, CSR section ownership, data consistency initiatives).
Contribute substantially to protocol development, CRF design, ICF updates, and alignment of data standards with downstream regulatory requirements.
Drive ongoing clinical data review activities, including plausibility review, query trend analysis, and preparation for database lock.
Accountable for assigned clinical science deliverables supporting regulatory submissions, including CSR sections, briefing package content, and health authority response inputs.
Support preparation of regulatory documentation and responses to health authority questions.
Collaborate closely with Biostatistics, Data Management, Medical Writing, Medical Directors, Pharmacovigilance, and Clinical Operations to ensure alignment and submission readiness.
Participate in study team meetings and represent Clinical Science in sub-team discussions.
May serve as Clinical Science lead for smaller or supportive studies, based on experience and study complexity.
Mentor Senior Clinical Scientists and Clinical Scientists as appropriate.
Proactively identify risks, propose mitigation strategies, and escalate significant issues as appropriate to Directors or Senior Directors.
Contribute to cross-functional discussions to support eSective and eSicient study execution.