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About the Role
The Senior Director of Safety Surveillance is a senior leader responsible for overseeing and/or leading safety development activities, including scientific innovation and enablement across various disciplines relevant to clinical safety and pharmacovigilance. This role ensures the continuous delivery of effective scientific and pharmacovigilance activities in line with regulatory and stakeholder requirements, requiring an extensive understanding of the operating environment to anticipate developments and implement improvements.
Responsibilities
- Establish and provide effective leadership, mentorship, and accountability for a global team, ensuring the quality of their work in building and maintaining safety processes.
- Manage team resources to align with GPS priorities and improve PV system quality.
- Provide subject matter expertise for the design, development, maintenance, and support of core GPS processes in compliance with global regulations.
- Provide strategic direction and leadership to the GPS team and cross-functional Development staff for core safety processes and required outputs.
- Offer expert consultation and direction for Development and filing teams regarding PV aspects of regulatory reports and clinical study documents.
- Lead and/or oversee the development of controlled documentation for the PV aggregate reporting process and other necessary processes.
- Collaborate with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance.
- Contribute to the development and maintenance of a PV quality system in line with global regulations.
- Ensure inspection readiness for global inspections by aligning processes and training with regulatory requirements.
- Act as subject matter expert (SME) for audits and inspections.
- Drive the development of controlled documentation for GPS-owned processes and ensure Safety's input in cross-functional settings.
- Strategically influence, implement, improve, and innovate through proposals that advance safety capabilities.
- Create and implement bespoke solutions to enable GPS stakeholders to deliver high-quality safety outputs addressing emerging challenges.
- Partner with cross-functional stakeholders to anticipate strategic requirements.
- Oversee resourcing, budget, and management of PV contract research organizations (PV CROs).
- Maintain expert knowledge of regulatory/legislative changes and trends to anticipate future requirements and apply best practices.
- Translate and expand new and established safety approaches across the RevMed portfolio for consistent safety surveillance.
- Identify, share, and promote good practice innovation for continuous process improvement.
- Coach and mentor stakeholders to ensure process continuity, consistency, and alignment.
- Build collaborative partnerships for GPS and its cross-functional partners.
- Collaborate with internal policy governance bodies to adapt core processes.
- Foster a culture of safety, compliance, and continuous improvement.
- Ensure clear and effective communication of safety information.
- Partner with PV systems personnel for the development and implementation of PV systems.
Requirements
- 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.
- 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.
- Strong clinical leadership and experience.
- Outstanding emotional intelligence.
- Proven ability to lead and develop PV personnel.
Skills
- Safety risk management
- Signal detection & management
- Comparative benefit-risk
- Aggregate reporting
- People management
- Technical expertise in PV
- Advanced safety data analytics
- PV systems
- Managing regulatory interactions
- Organizational and time management skills
- Influence and collaboration/teamwork capabilities
Location
- Hybrid
Work Type
- Hybrid
- Full-time
Experience Level
- Senior Director
- 12+ years of experience in PV or related field
- 6+ years of people management experience
Education Level
- Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD/MSc, or other post-graduate health professional qualification)
About the Company
- Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers.
- Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.
- Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
- Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
Equal Opportunity
- 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.
- We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines.
- These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
- Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process.
- All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
- If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.