Senior Medical Director, Early-Stage Clinical Development

Revolution Medicines•Redwood City, CA

4d•$346,000 - $397,000•Hybrid

About The Position

Revolution Medicines is seeking an experienced clinical science drug developer to serve as Senior Medical Director of Clinical Development, supporting molecules in clinical or late pre-clinical development. The role supports clinical science deliverables and enables effective execution of clinical development plans for molecules and their indications. Activities span early-stage clinical research and may extend to studies supporting regulatory submissions, including Breakthrough Therapy Designation or Accelerated Approval. The position leads clinical science aspects of clinical development plan strategy and documentation, represents the plan on program teams and forums, and oversees study-site training, program-level inquiries, medical and safety data reviews, and study reporting. The role may be assigned to complex, high-priority strategic studies and is expected to operate independently with self-directed leadership. It works cross-functionally with scientific, regulatory, and commercial teams, and may manage multiple direct reports. The role is based at the company’s Redwood City headquarters for onsite candidates; the posting is marked hybrid. The full-time position has a base pay range of $346,000–$397,000 USD for candidates working onsite in Redwood City, with salary adjusted for local market and determined by relevant factors. The company also describes competitive cash compensation, equity awards, benefits, and learning and development opportunities.

Requirements

MD degree; oncology training is preferred.
At least 7 years of clinical development experience in the pharmaceutical or biotechnology industry, and/or an academic or other clinical-trial setting.
Extensive experience applying data-analysis and interpretation principles and assessing clinical relevance in the pharmaceutical or biotechnology industry.
Experience independently generating trial designs; writing or amending protocols and informed consent forms; constructing appropriate case report forms; and coordinating cross-functionally.
In-depth therapeutic-area expertise and relevant clinical-trial experience, or a clear ability to adapt using transferable skills.
Strong knowledge of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations.
Ability to work effectively in cross-functional drug-development teams and integrate multiple perspectives into the clinical development plan.
Experience authoring regulatory briefing materials and responses to health-authority questions, and contributing to regulatory strategy and cross-functional coordination.
Demonstrated success driving study-level cross-functional strategy, including study design, feasibility, timeline and budget projections, and protocol amendment requirements.
Ability to drive discussions at internal decision-making and governance bodies.
Ability to build and maintain relationships with external key opinion leaders and contribute to engagements such as advisory boards and steering committees.
Experience engaging investigators to optimize trial conduct, including presenting at investigator meetings.
Strong teamwork orientation, leadership, communication, and interpersonal skills, including the ability to inspire, motivate, and mentor a diverse team.
Experience mentoring clinical scientists and experience or clear potential as an effective line manager.
Ability to build and maintain relationships with internal and external stakeholders.
Strong strategic thinking and analytical skills, including data-driven decision-making in a fast-paced environment.
Ability to assess trade-offs and determine priorities and goals.
Strong written communication and business presentation skills.
Passion for innovation and commitment to developing therapies that make a meaningful difference to patients.
Demonstrated leadership presence, adaptability, and flexibility.
Ability to anticipate needs and assess and manage business and organizational risks.

Nice To Haves

Experience in and understanding of early-phase drug development.
Significant contributions to the conception, conduct, and delivery of clinical development plans, including alignment with scientific governance.
Experience improving or developing core and sub-team processes, structures, systems, tools, and resources in the pharmaceutical or biotechnology industry.
Experience leading or supporting clinical development contributions to major regulatory submissions, such as first-in-human INDs, EOP2 briefing books (Type C/D), PIP/PSP, label negotiations, Breakthrough Therapy Designation, or Accelerated Review.
Ability to present clinical development aspects of programs to major health authorities, such as the FDA and EMA, by teleconference or in person.
Experience leading health-authority interactions.
Ability to establish clinical development strategy for CTA/EC submissions and responses to health-authority questions.
Experience collaborating on enterprise-level strategic initiatives with internal and external partners, including investigators, clinicians, scientists, KOLs, and groups across development, research, business development, commercial, and legal functions.
Influential leadership and ability to bring teams and individuals along.
Demonstrated courage and conviction in prior roles.
Demonstrated conflict-resolution skills.

Responsibilities

Lead clinical science and medical aspects of clinical development strategy and clinical documentation.
Represent the clinical development plan on appropriate teams, sub-teams, and forums.
Oversee training of study-site personnel and serve as the primary program-level contact for questions about the clinical development plan.
Oversee medical and safety data reviews and study reporting.
Lead or contribute to complex, high-priority strategic studies, operating independently where assigned.
Align cross-functional efforts with scientific, regulatory, and commercial objectives while executing the clinical development plan.
Lead, mentor, and contribute to a cross-functional clinical development team.
Oversee clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.
Establish and maintain relationships with clinical investigators, regulatory agencies, and other key stakeholders.
Gather, analyze, and interpret clinical data, providing strategic insights to inform decisions and program development.
Manage clinical development timelines, resource allocation, and milestone achievement.
Stay current on scientific advances and regulatory trends in clinical development.
Potentially manage multiple direct reports.