Senior Director, Global Patient Safety Surveillance

Responsibilities

• Establish and provide effective leadership, mentorship, and accountability for an experienced global team and for the quality of their work in building and maintaining safety processes and other safety development activities according to the values of Revolution Medicines.
• Management of team resources under their responsibility are deployed according to the priorities of GPS and for the improvement of PV system quality.
• Provide relevant subject matter expertise for the design, development, maintenance, and support of one or more core GPS processes (i.e. comparative benefit-risk, signal detection & management, risk management, aggregate reporting, etc.) in compliance with applicable Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Documentation Practices (GDocP), etc., in alignment with the company’s mission and objectives.
• Provide strategic direction and leadership where necessary to the GPS team and cross-functional Development staff to manage the core safety processes and support the execution/delivery of the required outputs (e.g. Risk Management Plans (RMPs), Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), etc.) in compliance with global regulatory requirements and following best practices.
• Provide expert consultation and direction for Development and filing teams where impactful 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).
• Lead and/or oversee the 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 compliance as 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 by ensuring processes and training reflect global regulatory requirements as applicable.
• Act as subject matter expert (SME) for audit and inspection where required.
• Drive development of controlled documentation for GPS owned processes as applicable and ensure that Safety’s voice is heard in cross-functional settings.
• Strategically influence, implement, improve, and innovate through the development of proposals that advance safety capabilities in line with the GPS mission, vision, goals, and long-term strategy.
• Create and implement bespoke solutions that enable GPS stakeholders to provide high-quality safety outputs that address emerging challenges in the healthcare practice setting against a dynamic regulatory landscape.
• Collaborate and close interface with internal policy governance bodies in adapting core processes in line with business needs and external requirements.
• Foster a culture of safety, compliance, and continuous improvement within GPS and broadly across the organization.
• Ensure clear and effective communication of safety information to internal and external stakeholders.
• Partner with PV systems personnel in the development and implementation of fit for purpose PV systems.

Qualifications

• Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD/MSc, or other post-graduate health professional qualification).
• Minimum of 12 years of experience in PV or related field within the pharmaceutical or biotechnology industry.
• Minimum of 6 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.