Senior Director, Global Patient Safety Science

About the role

The Senior Director, Global Patient Safety Science provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities as a member of the Global Patient Safety team. This position may have individual reporting to it depending on the program / portfolio being led.

Responsibilities

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles.
• Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.
• Provide medical safety input into the design and conduct of pharmacoepidemiology and observational studies.
• Plan and interpret safety data analyses, prepare and present safety data summaries to internal and external stakeholders.
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.
• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners).
• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.
• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).
• Develop and implement response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.
• Drive risk minimization strategies and take accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.
• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.
• Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.
• Lead representative for Safety Science during Health Authority meetings.
• Review publications, including abstracts, manuscripts, and speaker presentations.
• Train and mentor Safety Scientists.

Requirements

• 10 or more years of drug development experience in the pharmaceutical or related industry, of which at least 6 years include prior Safety Science experience, which includes performance of medical review, safety surveillance/signal detection, and other related risk management activities.
• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
• Mentor, and lead a high-performing Safety Science team.
• Excellent ability to evaluate, interpret and present scientific data with clarity.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
• Strong analytical and strategic thinking, problem-solving, and decision-making skills.
• Excellent communication, collaboration, and team management abilities.
• Extensive understanding of pharmacovigilance and risk management.
• Strong clinical leadership and experience.
• Outstanding emotional intelligence.

Qualifications

• Required Skills, Experience and Education:
• Preferred Skills:

Benefits

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. 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.

Pay

$244,000 - $305,000 USD

Schedule

Full-time