Medical Director, Early-Stage Clinical Development

Revolution Medicines•Redwood City, CA

2h•$295,000 - $339,000•Hybrid

About The Position

Revolution Medicines is seeking an experienced clinical science drug developer to serve as Medical Director of Clinical Development, supporting molecules in clinical or late pre-clinical development. The role supports clinical science deliverables and effective execution of clinical development plans for assigned molecules and indications. Its scope spans early-stage clinical research and may extend to studies supporting regulatory submissions, including Breakthrough Therapy Designation or Accelerated Approval. The Medical Director leads clinical science and medical aspects of development strategy and documentation, represents the development plan on relevant teams and forums, and supports study-site training, program-level inquiries, medical and safety data reviews, and study reporting. The role may involve complex, high-priority strategic studies and requires independent, self-directed leadership. The position works cross-functionally with scientific, regulatory, and commercial teams, oversees clinical trial design and execution, engages investigators and other stakeholders, analyzes clinical data, and manages timelines and resources. It may include managing multiple direct reports.

Requirements

MD; oncology training is preferred.
At least 5 years of clinical development experience in the pharmaceutical or biotech industry and/or an academic or other clinical-trial setting.
Extensive experience applying data analysis, interpretation, and clinical relevance principles and techniques in the pharmaceutical or biotech 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 transferable skills.
Strong knowledge of the 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 a clinical development plan.
Experience authoring regulatory briefing materials and writing responses to Health Authority questions, with the ability to contribute to regulatory strategy and cross-functional coordination.
Demonstrated success driving study-level cross-functional strategy, including study design, feasibility, timelines and budget projections, protocol amendments, and discussion at internal decision-making bodies.
Ability to build relationships with external key opinion leaders and contribute to engagements such as advisory boards, individual meetings, and steering committees.
Experience engaging investigators to optimize trial conduct, including presenting at investigator meetings, or a clear ability to do so.
Strong teamwork orientation and excellent leadership, communication, and interpersonal skills, including the ability to inspire, motivate, and mentor diverse teams.
Experience mentoring clinical scientists and experience or clear potential as an effective line manager.
Ability to build and maintain strong internal and external stakeholder relationships.
Strong strategic thinking and analytical skills, including data-driven decision-making, prioritization, and recognition of trade-offs in a fast-paced environment.
Strong written 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

Some experience in and understanding of early-phase drug development.
Significant contributions to clinical development plan conception, conduct, and delivery, including alignment with scientific governance.
Experience improving or developing core and sub-team processes, structures, systems, tools, or other resources in the pharmaceutical or biotech industry.
Experience leading or supporting clinical development contributions to major regulatory submissions, such as INDs for first-in-human studies, EOP2 briefing books, PIP/PSP, label negotiations, Breakthrough Therapy Designation, or Accelerated Review.
Ability to present clinical development aspects of programs to major health authorities such as FDA and EMA, including experience leading Health Authority interactions.
Experience setting clinical development strategy for CTA/EC submissions and responses to health-authority questions.
Collaborative experience on enterprise-level strategic initiatives with internal and external partners, including investigators, clinicians, scientists, key opinion leaders, and research, development, business development, commercial, and legal groups.
Influential leadership, with the ability to bring teams and individuals along.
Demonstrated courage, conviction, and conflict-resolution skills.

Responsibilities

Lead clinical science and medical 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 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 clinical science aspects of the Clinical Development Plan strategy and support its execution.
Perform responsibilities independently and provide self-directed leadership on potentially complex, high-priority strategic studies.
Align cross-functional efforts with scientific, regulatory, and commercial objectives.
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.
Build and maintain relationships with clinical investigators, regulatory agencies, and key stakeholders.
Gather, analyze, and interpret clinical data to inform decisions and guide program development.
Manage clinical development timelines, resource allocation, and milestones.
Stay current on scientific advances and regulatory trends in clinical development.
Potentially manage multiple direct reports.