Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company is seeking an experienced clinical science drug developer to serve as Senior Director of Clinical Development in support of its clinical-stage molecule(s).
Requirements
- A PhD, PharmD or equivalent is required.
- Minimum 10+ years experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities).
- 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 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.
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Significant learning and development opportunities
