Director, Global Patient Safety Science

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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:

The 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. The individual will be responsible for safety oversight and input into all aspects of study management across the portfolio. This position may have individual reporting to it depending on the program/portfolio being led. The Director of Safety Science serves as the lead for multiple or large complex strategically important developmental programs. Also works closely with the other functions as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities.

The Director Global Patient Safety Science will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g. disease under study safety profile of competitors mechanism of action etc.) and is accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle..

Specifically you will be responsible for:

• 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.

• Providing 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) which require expert contribution to the development of the product safety strategy.

• 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.).

• Developing 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.

• Evaluates risk minimization strategies and takes 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

• Reviews publications including abstracts manuscripts and speaker presentations.

• Trains and mentors Safety Scientists

• Consistently comply with all governing laws regulations RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills Experience and Education:

• 8 or more years of drug development experience in the pharmaceutical or related industry of which at least 4 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 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.

Preferred Skills:

• Demonstrated ability to lead and influence in a global matrix environment.

• 2 years of experience in Oncology clinical development

• Proficiency in managing regulatory interactions BLA/MAA experience.

• Strong organizational and time management skills with the ability to prioritize and manage multiple tasks effectively.

• Excellent influence and collaboration/teamwork capabilities.

• Strong interpersonal and communication (written and verbal) skills

The base salary range for this full-time position is $204000 to $255000 for candidates working onsite at our headquarters in Redwood City CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role level and location. Individual pay is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.

Please note that 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.

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 ourCCPA additional information please contact.

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