Senior Director, Clinical Development

About the role

We are seeking an experienced clinical science drug developer to serve as Senior Director of Clinical Development in support of Revolution Medicines' clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients. Lead clinical science aspects of the clinical development strategy and clinical documentation. Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting. Potential assignment to complex and high-priority strategic studies for Revolution Medicines' molecules, with expectation to perform responsibilities with independence and clear self-directed leadership. Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan. Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence. Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance. Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders. Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development. Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones. Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development. Potential to manage multiple direct reports Required Skills, Experience and Education: A PhD, PharmD or equivalent is required. The years of experience are based on clinical development or similar relevant experience. Minimum 10+ years experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities). Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry. Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally. In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills). Strong knowledge 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 is required. Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP. Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions. Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance. Proven ability to build and maintain strong relationships and contribute to interactions wit

Benefits

Additional Information

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at revolutionmedicines? Share your experience