Senior Director, Safety and Regulatory Affairs

6 days ago

Foster City, California, United States Mirum Pharmaceuticals Full time
Job Summary

Mirum Pharmaceuticals is seeking a highly experienced Vice President, Drug Safety to lead the development and implementation of global safety strategies across both clinical development and commercial products.

Key Responsibilities
  • Provide leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department.
  • Develop and implement global safety strategies to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure safety systems, staff, and procedures are in place to support a compliant global pharmacovigilance system.
  • Interface with vendors, external experts, business partners, investigators, and government agencies.
  • Oversee the Mirum global PV system to enable compliance with global PV regulatory requirements.
  • Participate in creation of organizational strategy, goals, and objectives for the department and ensure implementation of business plans to support both US and international global safety strategies.
  • Maintain awareness of new and emerging safety concerns and related communications to the competent authorities in a timeframe appropriate to the benefit-risk assessment of Mirum's products.
  • Responsible for all medical safety aspects of clinical development and post-market surveillance of medicinal products in the Mirum portfolio.
  • Strategic oversight and overall responsibility of commercial safety reporting requirements for US, EU, and other international territories, as required.
  • Management, oversight, and mentorship of staff able to set the strategy for future Drug Safety & PV department build and planning.
  • Partner with clinical development representatives to lead safety signal assessments and validate safety signals.
  • Participate in health authority interactions (both written and verbal) and inspections regarding safety risk management; may also oversee team members who support such interactions.
  • Oversight of Drug Safety Committees & Core Safety Information.
  • Contribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, label negotiations, etc.
  • Oversee, write, or review of periodic aggregate/safety reports.
  • Perform Benefit-Risk Assessments in collaboration with Clinical Development, as required.
  • Ensure compliance with global safety requirements and inspection readiness, including root-cause analyses.
  • Manage relationships with clients and team members providing expert safety knowledge.
Requirements
  • MD, PharmD, or equivalent degree.
  • Minimum of fifteen (15+) years Pharmacovigilance experience with at least five (5) years of department management experience.
  • Experience in building teams, directly or matrixed, and leading projects.
  • Experience in risk management strategies and signal detection strategies.
  • Robust knowledge of global PV requirements.
  • Experience overseeing safety/PV vendors.
  • Experience with regulatory authority inspections.
  • Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products.
  • Strong business acumen and ability to negotiate and collaborate with cross-functional partners to achieve department and company goals.
  • Effective written, verbal communication, and interpersonal, relationship-building skills.
  • Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
  • Organized, attention to detail, and able to meet timelines in a fast-paced environment.
  • Able to work with a high level of autonomy and independence.
  • Knowledge and understanding of regulatory requirements for product approval and compliance in North America and Europe.

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