Senior Director, Clinical Science, Early-Stage Clinical Development

Revolution Medicines, Redwood City, California +1

The role

We are seeking an experienced clinical science drug developer to serve as Senior Director, Clinical Science, 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, driving the development of transformative therapies for patients.

Lead clinical science aspects of the clinical development strategy and clinical documentation.

All jobs

Senior Director, Clinical Science, Early-Stage Clinical Development

Revolution Medicines, Redwood City, California +1

The role

You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

Lead clinical science aspects of the clinical development strategy and clinical documentation.

What you need

Bachelor’s Degree (life sciences preferred) plus Advanced Clinical/Science Degree is required (e.g., PharmD, PhD, MSN, MPH, etc).
Minimum 7+ years experience in clinical development in the pharmaceutical/biotech industry and/or academic/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 (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.

Nice to have

Created significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.
Experienced in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.
Led or supported clinical development contributions to major regulatory submissions (e.g. IND for First-in-Human studies, EOP2 briefing books (Type C/D); 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 interactions.
Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.
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 (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.
Demonstrated courage and conviction in past positions and responsibilities. Excellent skills in conflict resolution.

#LI-GL1 #LI-Onsite

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

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.

Senior Director, Clinical Science, Early-Stage Clinical Development

The role

Senior Director, Clinical Science, Early-Stage Clinical Development

The role

What you need

Nice to have

Pay and benefits

About Revolution Medicines

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Revolution Medicines