Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

We are seeking a highly skilled and experienced Head of Drug Safety to join our dynamic team. The successful candidate will lead our Drug Safety department, overseeing the safety assessment and management of our drug products throughout their lifecycle. This critical role will involve strategic leadership, collaboration with cross-functional teams, and ensuring compliance with regulatory requirements to safeguard patient well-being. 

• Develop and implement the strategic vision for the Drug Safety department, aligning with the company’s goals and objectives.

• Provide leadership and guidance to a team of drug safety professionals, fostering a culture of excellence, collaboration, and continuous improvement.

• Drive initiatives to optimize drug safety processes, systems, and workflows to enhance efficiency and effectiveness.

• Oversee the evaluation of safety data from preclinical studies, clinical trials, post-marketing surveillance, and literature sources to assess and mitigate potential risks associated with our drug products.

• Lead the preparation of safety reports, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs), for submission to regulatory authorities.

• Collaborate with cross-functional teams to develop risk minimization strategies and safety interventions as necessary.

• Ensure compliance with global regulatory requirements and guidelines related to pharmacovigilance and drug safety.

• Serve as the primary point of contact for regulatory agencies on drug safety matters, including participation in regulatory inspections and audits.

• Keep abreast of emerging regulations and industry trends to proactively adapt drug safety processes and practices.

• Lead the ongoing monitoring and analysis of safety data to detect potential signals of adverse events or emerging safety concerns.

• Conduct thorough investigations of safety signals, including the review of individual case reports, aggregate data, and relevant scientific literature.

• Collaborate with stakeholders to assess the clinical relevance and potential impact of identified signals and recommend appropriate actions.

• Work closely with clinical development, medical affairs, regulatory affairs, and other relevant departments to integrate drug safety considerations into product development strategies and clinical trial designs.

• Provide expert guidance and support to cross-functional teams on safety-related issues, including protocol development, risk assessment, and safety monitoring activities.

Required Skills, Experience and Education:

• Advanced degree in pharmacy, medicine, life sciences, or a related field.

• Extensive experience (minimum 8-10 years) in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry, with progressive leadership responsibilities.

• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).

• Strong leadership and management skills, with a track record of building and developing high-performing teams.

• Excellent communication, interpersonal, and influencing skills, with the ability to effectively collaborate with internal and external stakeholders.

• Proven ability to think strategically, drive innovation, and implement process improvements in drug safety operations.

• Experience interacting with regulatory agencies and participating in regulatory inspections and audits is highly desirable.

Preferred Skills, Experience and Education:

• PharmD, MD, or PhD preferred.

The expected salary range for this role is $265,000 to $350,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary 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 is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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