Revolution Medicines is seeking a Medical Director to support the clinical-stage molecule(s) in the oncology portfolio. The ideal candidate will have a strong foundation in clinical medicine, oncology experience, and proven expertise in clinical trial data review, cleaning, and regulatory submission preparation.
Requirements
- M.D. (or equivalent international medical degree, MBBS, MBChB,)
- Board certification/eligibility in Oncology;
- Subspecialty training in GI malignancies (strongly preferred);
- Minimum 5+ years' experience in clinical development in solid tumors generally, and GI Tumors (strongly preferred);
- Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities 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.
- 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.
- 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
