Revolution Medicines · 1 month ago
Senior Medical Director
Redwood City, California, United States
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$236K/yr - $295K/yr
13+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Senior Medical Director will oversee clinical science deliverables and ensure the integrity of clinical data for regulatory submissions, playing a crucial role in the clinical development strategy and execution.
Health CareLife ScienceMedical
Responsibilities
Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio
Apply medical expertise to guide query resolution, adjudication of outliers, and clinical plausibility review during data cleaning
Collaborate with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements
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
Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings
Support the Medical Monitors Medical Lead and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs)
Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents
Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data
Lead clinical data review meetings, escalating issues and recommending solutions to maintain data reliability and consistency
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
Work closely with Data Management, Medical Monitors, CRO, Clinical Operations to ensure that site-level data collection, query resolution and other activities align with submission requirements
Partner with RevMed’s Pharmacovigilance to reconcile safety databases with clinical trial datasets
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
Qualification
Required
M.D. (or equivalent international medical degree, MBBS, MBChB,) with board certification/eligibility in Oncology or Hematology-Oncology; subspecialty training in GI malignancies strongly preferred
Minimum 13+ years' experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities)
Minimum 5 years of experience in late-stage clinical development within the biotech/pharmaceutical industry
Demonstrated experience with medical data review, cleaning for NDA or BLA filings and regulatory submissions
Strong working knowledge of data cleaning, database lock processes, and clinical data review
Proven ability to lead cross-functional clinical teams and contribute to strategic development plans
Excellent written and verbal communication skills for both scientific and regulatory audiences
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 with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.)
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 team members. 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
Ability to thrive in a fast-paced, collaborative biotech environment
Preferred
Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry
Has led clinical development contributions to major regulatory submissions (e.g. (s)NDA, (s)BLA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) is a major plus
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 collaborate 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 (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - 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
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase