Medical Director, Early-Stage Clinical Development

Revolution Medicines•Redwood City, CA

5d•Hybrid

About The Position

Revolution Medicines is seeking an experienced clinical science drug developer to serve as Medical Director of Clinical Development for one or more 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 include studies supporting regulatory submissions, including Breakthrough Therapy Designation or Accelerated Approval. The Medical Director leads clinical science aspects of the Clinical Development Plan strategy and clinical documentation, represents the plan on relevant teams and forums, and may take independent leadership of complex, high-priority strategic studies. The role oversees study-site personnel training, medical and safety data reviews, and study reporting, and serves as a program-level point of contact for questions about the development plan. It also involves cross-functional coordination with scientific, regulatory, and commercial teams; clinical trial design and execution; investigator and stakeholder relationships; clinical data interpretation; and management of development timelines and resources. The position may include managing multiple direct reports and mentoring clinical development professionals. The role is based onsite at the company’s Redwood City, California headquarters for the stated salary range; the posting also includes a hybrid designation. Base pay is $295,000–$339,000 USD for the onsite Redwood City range, subject to adjustment for local market and individual factors. The company describes its total rewards program as including competitive cash compensation, equity awards, benefits, and learning and development opportunities.

Requirements

MD; oncology training is preferred.
At least 5 years of experience in clinical development 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 pharmaceutical or biotechnology development.
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.
Proven ability to work effectively within cross-functional drug-development teams and integrate multiple perspectives into a Clinical Development Plan.
Experience authoring regulatory briefing packs and writing responses to Health Authority questions, with the ability to contribute to regulatory strategy and cross-functional coordination.
Demonstrated success driving study-level strategy, including study design, feasibility, timeline and budget projections, and protocol amendment requirements.
Ability to drive relevant discussions in internal decision-making and governance forums.
Ability to build and maintain relationships with external key opinion leaders and contribute to interactions that optimize clinical programs.
Experience, or clear ability, in investigator engagement to optimize clinical trial conduct, including presenting at investigator meetings.
Strong teamwork orientation and excellent leadership, communication, and interpersonal skills; ability to inspire, motivate, and mentor across diverse teams.
Experience mentoring other clinical scientists and experience or clear potential as an effective line manager.
Strong strategic thinking and analytical skills, including the ability to make data-driven decisions in a fast-paced environment.
Ability to recognize 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 in patients’ lives.
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, and other resources in the pharmaceutical or biotechnology industry.
Experience leading or supporting clinical development contributions to major regulatory submissions, such as INDs for first-in-human studies, EOP2 briefing books (Type C/D), PIP/PSP, label negotiation, Breakthrough Therapy Designation, or Accelerated Review.
Ability to present clinical development aspects of programs to major Health Authorities such as 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, development, research, business development, commercial, and legal groups, with demonstrable outcomes.
Influential and inspiring leadership, including the ability to bring teams and individuals along.
Demonstrated courage and conviction in previous positions and responsibilities.
Demonstrated 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 point of contact for Clinical Development Plan questions and inquiries.
Oversee medical and safety data reviews and study reporting.
Lead clinical development work for complex, high-priority strategic studies, with independence and self-directed leadership as needed.
Align clinical development work cross-functionally with scientific, regulatory, and commercial objectives.
Lead, mentor, and contribute to cross-functional clinical development teams; potentially manage multiple direct reports.
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 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 advancements and regulatory trends in clinical development.
Contribute to trial strategy, including study design, feasibility, timelines, budget projections, and protocol amendments.
Support regulatory activities, including authoring briefing materials and responding to Health Authority questions.
Engage with external key opinion leaders and investigators, including through advisory boards, individual engagements, steering committees, and investigator meetings.