Revolution Medicines
Senior Director, Clinical Development
Revolution Medicines, San Francisco, California, United States, 94199
Senior Director, Clinical Development
Revolution Medicines is a clinical‑stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS‑addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Responsibilities
Lead clinical science aspects of the clinical development strategy and clinical documentation.
Represent the clinical development plan on appropriate teams and sub‑teams, oversee training of study site personnel, and act as primary point‑of‑contact for questions regarding the CDP at a program level.
Oversee medical/safety data reviews and study reporting.
Potential assignment to complex and high‑priority strategic studies expected to perform responsibilities with independence and clear self‑directed leadership.
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.
Potential to manage multiple direct reports.
Qualifications
Bachelor’s Degree in life sciences plus an advanced clinical/science degree (PharmD, PhD, MS, MSN, MPH, etc.) required.
Minimum 13+ years of experience in clinical development required.
Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
Experience in independent generation of trial design, protocol writing, and constructing appropriate CRF.
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 other relevant guidelines and regulations.
Proven ability to work effectively within cross‑functional teams and to integrate multiple perspectives into the clinical development plan.
Experience authoring regulatory briefing packs and responding to Health Authority questions.
Demonstrated success in driving study‑level strategy, including feasibility, timelines, and budget projections.
Strong written and business presentation skills.
Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients’ lives.
Preferred Skills
Significant contributions to clinical development plan conception, conduct, and delivery.
Experience in ongoing enhancements of core and sub‑team processes, structures, systems, tools, and resources.
Leadership in 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.
Effective health authority interaction and strategy for CTA/EC submissions and response to health authority questions.
Collaboration behaviors on enterprise‑level strategic initiatives with internal and external partners and stakeholders.
Influential and inspiring leader with proven ability to bring teams and individuals along.
Demonstrated conflict resolution and courageous conviction in past positions.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, ancestry, 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.
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Responsibilities
Lead clinical science aspects of the clinical development strategy and clinical documentation.
Represent the clinical development plan on appropriate teams and sub‑teams, oversee training of study site personnel, and act as primary point‑of‑contact for questions regarding the CDP at a program level.
Oversee medical/safety data reviews and study reporting.
Potential assignment to complex and high‑priority strategic studies expected to perform responsibilities with independence and clear self‑directed leadership.
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.
Potential to manage multiple direct reports.
Qualifications
Bachelor’s Degree in life sciences plus an advanced clinical/science degree (PharmD, PhD, MS, MSN, MPH, etc.) required.
Minimum 13+ years of experience in clinical development required.
Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
Experience in independent generation of trial design, protocol writing, and constructing appropriate CRF.
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 other relevant guidelines and regulations.
Proven ability to work effectively within cross‑functional teams and to integrate multiple perspectives into the clinical development plan.
Experience authoring regulatory briefing packs and responding to Health Authority questions.
Demonstrated success in driving study‑level strategy, including feasibility, timelines, and budget projections.
Strong written and business presentation skills.
Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients’ lives.
Preferred Skills
Significant contributions to clinical development plan conception, conduct, and delivery.
Experience in ongoing enhancements of core and sub‑team processes, structures, systems, tools, and resources.
Leadership in 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.
Effective health authority interaction and strategy for CTA/EC submissions and response to health authority questions.
Collaboration behaviors on enterprise‑level strategic initiatives with internal and external partners and stakeholders.
Influential and inspiring leader with proven ability to bring teams and individuals along.
Demonstrated conflict resolution and courageous conviction in past positions.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, ancestry, 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