Executive Director, Global Patient Safety Surveillance

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 scientists 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 Executive Director of Safety Surveillance to join our dynamic team. The Executive Director of Safety Surveillance is a senior executive responsible for the leadership oversight strategy and execution of the pharmacovigilance aggregate reporting process and risk management as it pertains to communication and coordination of risk management activities in partnership with safety science in support of Revolution Medicines products over the product development life cycle. The Executive Director of Safety Surveillance will ensure that high quality aggregate reporting and risk management practices will enable compliance with global regulations demonstrating oversight of the pharmacovigilance system. This will lead to timely and accurate communication of important safety information allowing health authorities prescribers and patients to ensure safe use of Revolution Medicines products in the development and post-market settings.

This critical role will require strategic scientific and clinical leadership collaboration with cross-functional teams technical expertise experience and understanding of global pharmacovigilance regulations and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being.

Responsibilities include:

Pharmacovigilance Aggregate Reporting

• Develop and implement the global pharmacovigilance (PV) aggregate reporting strategy in compliance with Good Clinical Practice (GCP) Good Vigilance Practice (GVP) and Good Documentation Practices (GDocP) in alignment with the companys mission and objectives.

• Provide strategic direction and leadership to the Global Patient Safety (GPS) team and cross-functional Development staff to manage the process production and preparation of high-quality PV aggregate reports (i.e. DSUR PSUR) required by health authorities ensuring accuracy timely completion and submission in compliance with global regulatory requirements and following best practices.

• Collaborate and cooperate with Regulatory Medical Writing to ensure consistency in writing style and process.

• Oversee the resourcing budget and management of PV contract research organizations (PV CROs) in aggregate reporting activities as needed.

• Lead development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed.

• Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European complianceas applicable.

• Contribute to the development and maintenance of a PV quality system in line with global regulations (i.e. GCP GVP) enabling demonstration of quality effectiveness and control.

• Ensure inspection readiness for global inspections related to PV aggregate reporting by ensuring processes and training reflect global regulatory requirements as as subject matter expert (SME) for audit and inspection.

• Foster a culture of safety compliance and continuous improvement within the PV function and broadly across the organization.

• Promote continuous professional development and ensure the team is equipped with the latest regulatory intelligence related to aggregate reporting and GDocP.

Risk Management

• Oversee PV risk management practices for GPS ensuring compliance with global regulations as it pertains to the risk management process and development of Risk Management Plans (RMPs) additional Risk Minimization Measures (aRMMs) and Risk Evaluation Mitigation Strategies (REMs) as applicable across the development and marketed products portfolio.

• In partnership with Regulatory Labeling Safety Science and cross-functional stakeholders contribute to the development of Company Core Safety Information (CCSI) Company Core Data Sheet (CCDS) and local labels.

• Develop and maintain relationships across Revolution Medicines particularly in Clinical Operations Clinical Development Clinical Data Science Regulatory Affairs Quality Assurance Medical Affairs Commercial and other departments as appropriate to ensure compliance with PV risk management measures and ensure an integrated PV system.

Global Product Safety Leadership Collaboration Influence Compliance and Technical Expertise

• Drive development of controlled documentation for GPS sponsored processes as applicable and ensure that Safetys voice is heard in cross-functional settings.

• Provide expert consultation and direction for Development and filing teams as it relates to PV portions of regulatory reports and clinical study documents (including Clinical Protocols Informed Consent Forms Investigator Brochures NDA filing packages (i.e. Module 2: Clinical Overview Clinical Summary Integrated Summary of Safety (ISS) Integrated Summary of Efficacy (ISE) safety narratives) and labeling strategy.

• Build mentor and lead a high-performing global PV team.

• Ensure clear and effective communication of safety information to internal and external stakeholders.

• Provide expertise in development and approval of PV agreements (PVAs) and safety data exchange agreements (SDEA) with applicable partners as they pertain to safety activities.

• Partner with PV systems personnel in the development and implementation of fit for purpose PV systems.

Required Skills Experience and Education:

• Advanced degree in Medicine Pharmacy or a related field.

• Minimum of 15 years of experience in PV or related field within the pharmaceutical or biotechnology industry.

• Minimum of 10 years of experience managing people; strong people management skills willingness to help others and ability to deal with ambiguity.

• Proven track record of leadership in PV.

• Experience and success in interacting with Regulatory Authorities (i.e. FDA EMA) at type C B pre-BLA/MAA meetings Advisory Committee meetings or other scientific advice forums.

• In-depth knowledge of global PV regulations and guidelines (i.e. ICH GxP) and a record of compliance with these standards.

• Strong analytical and strategic thinking problem-solving and decision-making skills.

• Excellent communication collaboration and team management abilities enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company.

• Technical expertise in PV.

• Strong clinical leadership and experience.

• Outstanding emotional intelligence.

• Proven ability to lead and develop PV personnel.

Preferred Skills:

• MD JD PharmD PhD preferred.

• Experience with advanced safety data analytics and PV systems.

• Demonstrated ability to manage complex projects and work effectively in a matrixed organization.

• Proficiency in managing regulatory interactions.

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

• Excellent influence and collaboration/teamwork capabilities.

• BLA/MAA experience.

The base salary range for this full-time position is $256000 to $320000 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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