Senior Director, Safety Science
About The Position
The Clinical Development team is seeking a Senior Director, Safety Science to establish, lead, and scale safety science and pharmacovigilance (PV) at Maze. This role will serve as Maze’s first internal Safety Science leader, with responsibility to build the safety function from the ground up while providing enterprise-level leadership across the clinical portfolio. In this highly visible and hands-on leadership role, you will define and own the safety strategy across our clinical programs, spanning both common and rare diseases in nephrology and cardiometabolic indications. You will have end-to-end responsibility for safety surveillance, adverse event reporting, risk management, and PV governance, while partnering closely with Clinical Development, Regulatory, Biostatistics, and Clinical Operations. As Maze advances programs from early to late-stage development, you will play a critical role in shaping safety strategy, influencing decision-making, and ensuring patient safety remains central to our work. This position reports to the Head of Clinical Development.
Requirements
- Advanced degree in health sciences (MD/DO, PharmD, PhD) with 7+ years of experience in pharmacovigilance and drug safety, including hands-on operational leadership and strategic oversight of late-stage clinical programs and/or regulatory submissions
- Demonstrated experience building or standing up safety science or PV capabilities in a resource-constrained or high-growth environment
- Deep and current knowledge of global pharmacovigilance regulations, safety requirements, and evolving regulatory expectations.
- Experience with medical review of individual case reports (ICSRs), signal detection, cumulative safety assessments, and risk management planning
- Proven ability to move fluidly between strategic leadership and detailed execution, particularly in early-stage of first-in-function roles
- Track record of influencing development, regulatory, and portfolio decisions at senior and governance levels
- Experience managing and transitioning work from external consultants and vendors to internal teams
- A collaborative, ethical, and inclusive leadership style with the ability to inspire followership and alignment across functions
- Ability to travel domestically up to 10-15% for internal and external meetings
Responsibilities
- Lead and build Maze’s safety science and PV function, scaling the strategy, activities, and team to support the development lifecycle from early clinical development through late-stage studies and regulatory submissions
- Serve as the primary internal owner of safety science and PV activities, directly overseeing day-to-day safety operations while establishing future-state processes and capabilities
- Lead safety surveillance and signal identification activities, proactively identifying risks and developing mitigation strategies
- Provide strategic and operational oversight for case processing, adverse event reporting, and regulatory compliance
- Oversee the preparation, review, and submission of aggregate safety reports and safety sections of clinical and regulatory documents
- Author and maintain safety-related content for clinical and regulatory documents, while establishing scalable content standards and governance for future team expansion.
- Guide benefit-risk assessments and safety-related recommendations that inform program progression and development decisions
- Establish Maze’s Safety Science and PV function, defining vision, operating model and fostering a culture of accountability, development, and scientific rigor
- Partner cross-functionally to develop and execute Safety Management plans aligned with program and corporate objectives
- Serve as a subject matter expert in internal governance forums and external discussions with KOLs, advisors, and health authorities.
- Influence senior stakeholders across functions to align on safety strategy, risk tolerance, and development trade-offs
- Oversee and directly engage in operational PV activities as needed, including close collaboration with external consultants supporting case processing and compliance
- Design and evolve a scalable PV operating model that transitions from external support to internal ownership over time
- Provide strategic direction for outsourced PV activities, including CROs, consultants, and vendors
- Anticipate operational or compliance risks and proactively implement solutions that protect patients and enable program success
Benefits
- competitive medical, dental, and vision insurance
- mental health offerings
- equity incentive plan
- 401(k) program with employer match
- generous holiday and PTO policy
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
