Talent.com
Senior Medical Director
Senior Medical DirectorRevolution Medicines • San Francisco, CA, United States
Senior Medical Director

Senior Medical Director

Revolution Medicines • San Francisco, CA, United States
5 days ago
Job type
  • Full-time
Job description

Senior Medical Director – Revolution Medicines

Location : Redwood City, CA (Onsite)

  • Base pay : $204,000 — $255,000 USD. Additional compensation includes comprehensive equity awards, robust cash bonuses, strong benefits, and significant learning and development opportunities.

Opportunity

We are seeking an experienced clinical science drug developer to serve as Senior Medical Director in support of Revolution Medicines’ clinical‑stage molecule(s). 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). You will be a pivotal figure at the interface of clinical development, regulatory science, clinical data, and clinical operations, instrumental in preparing pivotal datasets for successful global filings.

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 regarding the CDP at a program level, oversee 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 regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS) and Clinical Study Reports (CSRs).
  • Prepare 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.
  • Possibly take on complex and high‑priority strategic studies for Revolution Medicines’ molecules, performing 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 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.

    • Required Skills, Experience and Education

  • 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 (Pharma R&D experience outside of a clinical development role also considered).
  • 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 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 scientific and regulatory audiences.
  • Extensive experience with data analysis, interpretation and clinical relevance in the pharmaceutical / biotech industry.
  • Experience in independent generation of trial design, protocol writing / ICF 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 GCP, ICH, FDA, EMA and related guidelines.
  • Proven ability to work efficiently within cross‑functional teams, integrating multiple perspectives into the CDP.
  • Experience authoring regulatory briefing packs, writing responses to Health Authority questions and contributing to strategic regulatory activities.
  • Proven ability to drive study‑level strategy, such as study design, feasibility and timelines / budget projections.
  • Strong relationship‑building skills with external key opinion leaders to optimize clinical programs.
  • Experience in investigator engagement to optimize clinical trial conduct, including presenting at investigator meetings.
  • Strong orientation to teamwork with excellent leadership, communication and interpersonal skills.
  • Experience in mentoring other team members and potential for effective line management.
  • Expertise in building and maintaining strong relationships with internal and external stakeholders.
  • Superior strategic thinking and analytical skills, capable of making data‑driven decisions in a fast‑paced environment.
  • Strong written and business presentation skills.
  • Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients’ lives.
  • Demonstrated strong leadership presence, adaptability and flexibility.
  • Ability to anticipate needs, assess and manage business and organizational risks.
  • Ability to thrive in a fast‑paced, collaborative biotech environment.

    • Preferred Skills

  • Experience in ongoing enhancements / development of core and sub‑team processes, structures, systems, tools and other resources in the biotech / biopharmaceutical industry.
  • Hands‑on experience leading clinical development contributions to major regulatory submissions (e.g., NDA, BLA, PIP / PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review).
  • Proven ability to present the clinical development aspects of a program to key health authorities (FDA, EMA, etc.) and lead Health Authority interactions.
  • Ability to develop the clinical development strategy for CTA / EC submissions and responses to health authority questions.
  • Demonstrated collaboration on enterprise‑level strategic initiatives with a variety of internal and external partners, resulting in measurable outcomes that enhance strategic goals.
  • Influential and inspiring leadership, with proven conflict resolution skills.
  • Proven courage and conviction in past positions and responsibilities.

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

    Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

    #J-18808-Ljbffr

    Create a job alert for this search

    Senior Medical Director • San Francisco, CA, United States

    Related jobs
    Director 2, Healthcare Technology Management

    Director 2, Healthcare Technology Management

    Sodexo • Larkspur, CA, US
    Full-time
    Role Overview : Lifesaving technology, powered by you.Your expertise impacts the lives of others.Sodexo's growing Healthcare Technology Management (HTM) Division is currently seeking an HTM Director...Show more
    Last updated: 23 hours ago • Promoted
    Medical Director

    Medical Director

    RH Talent • San Francisco, CA, United States
    Full-time
    A clinical-stage biotech is seeking a Medical Director to help lead oncology programs across Phase 1–Phase 3.This position guides strategy, oversees trial execution, and supports major clinical and...Show more
    Last updated: 8 days ago • Promoted
    US Medical Senior Director, Medical Affairs Evidence Generation

    US Medical Senior Director, Medical Affairs Evidence Generation

    Gilead Sciences • San Francisco, CA, United States
    Full-time
    US Medical Senior Director, Medical Affairs Evidence Generation.We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action mo...Show more
    Last updated: 27 days ago • Promoted
    Area Director Behavioral Health

    Area Director Behavioral Health

    Kaiser • UNION CITY, California, United States
    Full-time
    In conjunction with Behavioral Health Chiefs of Services, responsible for the operational, service and fiscal management of psychiatric patient care services across multiple facilities with subordi...Show more
    Last updated: 1 day ago • Promoted
    Senior Medical Director, Clinical Development

    Senior Medical Director, Clinical Development

    Septerna • San Francisco, CA, United States
    Full-time
    Senior Medical Director, Clinical Development.Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life‑changing medicines. The company’s Native Complex Platf...Show more
    Last updated: 3 days ago • Promoted
    Director, Nonclinical Development

    Director, Nonclinical Development

    Amber Bio • Santa Clara, CA, US
    Full-time
    Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field fr...Show more
    Last updated: 5 days ago • Promoted
    Senior Director, Medical Excellence Strategic Programs

    Senior Director, Medical Excellence Strategic Programs

    Gilead Sciences, Inc. • Foster City, CA, United States
    Full-time
    Senior Director, Medical Excellence Strategic Programs.At Gilead, we’re creating a healthier world for all people.For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-...Show more
    Last updated: 3 days ago • Promoted
    Medical Director

    Medical Director

    Ethos Veterinary Health • Redwood City, CA, United States
    Full-time
    SAGE Veterinary Centers - Redwood City.Located in Silicon Valley, about 25 miles from San Francisco, our hospital values true collaboration among Specialty, Emergency, and Urgent Care services unde...Show more
    Last updated: 30+ days ago • Promoted
    Medical Director

    Medical Director

    89bio Inc. • San Francisco, CA, United States
    Temporary
    The company is focused on rapidly advancing its lead candidate,.Phase 3 clinical development for the treatment of metabolic. Pegozafermin is a specifically engineered, potentially best-in-class fibr...Show more
    Last updated: 5 days ago • Promoted
    Senior Medical Director, Clinical Development

    Senior Medical Director, Clinical Development

    Olema Oncology • San Francisco, CA, United States
    Full-time
    Senior Medical Director, Clinical Development.Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estroge...Show more
    Last updated: 5 days ago • Promoted
    Medical Director, Oncology

    Medical Director, Oncology

    SciPro • San Francisco, CA, United States
    Full-time
    Be among the first 25 applicants.This range is provided by SciPro.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Clinical Development Consultan...Show more
    Last updated: 4 days ago • Promoted
    Director, Clinical Excellence, East

    Director, Clinical Excellence, East

    Calyxo, Inc. • Pleasanton, CA, United States
    Full-time
    The company was founded in 2016 to address the profound need for improved kidney stone treatment.Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resourc...Show more
    Last updated: 25 days ago • Promoted
    Sr. Director - Health Systems Liaisons - West Team Lead (REMOTE)

    Sr. Director - Health Systems Liaisons - West Team Lead (REMOTE)

    Kaye / Bassman International • San Jose, CA, US
    Remote
    Full-time
    Kaye / Bassman International is a leading executive search firm that has been filling roles for Pharma and Biotech clients for over 35 years. Our Medical Affairs search practice is led by Michael Piet...Show more
    Last updated: 5 hours ago • Promoted • New!
    Senior Medical Director

    Senior Medical Director

    Summit Therapeutics, Inc. • Menlo Park, CA, United States
    Full-time
    Ivonescimab, known as SMT112, is a novel, potential first‑in‑class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD‑1 with the anti‑angiogenesis effec...Show more
    Last updated: 3 days ago • Promoted
    Senior Medical Director

    Senior Medical Director

    San Francisco Health Plan • San Francisco, CA, United States
    Full-time
    Reporting to the Chief Medical Officer (CMO), the Senior Medical Director provides strategic clinical leadership and oversight for SFHP's Medical Directors and Quality Review teams.You will be the ...Show more
    Last updated: 8 days ago • Promoted
    Senior Medical Director, Global Oncology Clinical Development

    Senior Medical Director, Global Oncology Clinical Development

    Summit Therapeutics, Inc. • Menlo Park, CA, United States
    Full-time
    A leading biopharmaceutical company seeks a Senior Medical Director – Clinical Development to oversee global Phase 3 clinical trials and BLA filings. The ideal candidate will have significant oncolo...Show more
    Last updated: 3 days ago • Promoted
    Medical Director

    Medical Director

    89bio • San Francisco, CA, United States
    Temporary
    Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an e...Show more
    Last updated: 8 days ago • Promoted
    Global Senior Medical Director – Oncology Clinical Trials

    Global Senior Medical Director – Oncology Clinical Trials

    Summit Therapeutics Sub, Inc. • Menlo Park, CA, United States
    Full-time
    A leading biopharmaceutical company seeks a Senior Medical Director to lead global Phase 3 trials and oversee BLA filings. The ideal candidate will have extensive oncology experience, a proven track...Show more
    Last updated: 3 days ago • Promoted