Medical Director, Early-Stage Clinical Development

Revolution Medicines; San Francisco (CA); On-site; USD 295,000 - 339,000; Full time

Job summary

Revolution Medicines in San Francisco seeks a Medical Director of Clinical Development. The role involves leading clinical science activities in support of drug development, overseeing clinical trial design, and collaborating with cross-functional teams. Candidates must have an MD, extensive clinical development experience, and strong leadership skills. Responsibilities include managing timelines and fostering cross-functional collaboration to ensure successful execution of clinical plans. The salary ranges from $295,000 to $339,000 USD. Revolution Medicines is an equal opportunity employer.

Qualifications

• 5+ years of clinical development experience in the pharmaceutical/biotech industry or clinical trial setting.
• Extensive experience with data analysis relevant to drug development.
• Strong knowledge of GCP, ICH, FDA, and EMA guidelines.

Responsibilities

• Lead clinical science and medical aspects of the clinical development strategy.
• Oversee clinical trial design and execution.
• Manage timelines and resource allocation effectively.

Skills

Clinical development experience

Data analysis and interpretation

Protocol writing

Therapeutic area expertise

Leadership and teamwork

Regulatory interaction

Education

MD (oncology training preferred)

Job description

Introduction

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 includes several RAS(ON) inhibitors currently in clinical development.

The Opportunity

We are seeking an experienced clinical science drug developer to serve as Medical Director of Clinical Development in support of Revolution Medicines’ molecule(s) in clinical or late pre‑clinical development. 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 and may extend to studies supporting regulatory submissions including Breakthrough‑Therapy‑Designation (BTD) or Accelerated Approvals (AA). You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy.

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, act as primary point‑of‑contact for questions/enquiries 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 objectives 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

• MD (oncology training preferred) with 5+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic or other clinical trial setting; some experience in and understanding of early‑phase drug development preferred.
• 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, ICH, FDA, EMA and other relevant guidelines and regulations.
• 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, writing 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 with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees).
• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.
• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.
• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.
• Expertise in building and maintaining strong relationships with internal and external stakeholders.
• Superb strategic thinking and analytical skills, with the ability to make data‑driven decisions in a fast‑paced environment. Able to recognize trade‑off decisions and can determine priorities and goals.
• Strong written and business presentation skills is required.
• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients’ lives.
• Demonstrated strong leadership presence.
• Has demonstrated adaptability and flexibility.
• Anticipates needs, assesses and manages business and organizational risks.

Preferred Skills

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.
• Experience in ongoing enhancements/development of core and sub‑team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.
• Has led or supported clinical development contributions to major regulatory submissions (e.g. IND for First‑in‑Human studies, EOP2 briefing books, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review).
• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in‑person. Has led Health Authority interaction(s).
• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.
• Has demonstrated collaborative behaviors on enterprise‑level strategic initiatives with a variety of internal and external partners and stakeholders—including clinical investigators/clinicians, scientists and key opinion leaders (KOL), as well as internal groups such as other groups in development, research, business development, commercial, legal—resulting in demonstrable outcomes that have further enhanced strategic goals.
• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.
• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution.

Base Pay Salary Range

$295,000 - $339,000 USD

Equal Opportunity Statement

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, medical condition, and veteran status.