Senior Director, Safety Science

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 k nowledge of global pharmacovi

Benefits

Additional Information

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 . The Impact You'll Have In this role, you will combine deep safety scientific expertise with senior-level leadership and a willingness to operate in both strategic and executional modes . Safety Strategy & Oversight 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 Leadership & Collaboration 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 Operational Excellence 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 As a Senior Director, we also expect you to demonstrate the following Leadership Competencies: Communication and Influence Role models clear communication and open two-way conversations. Reinforces an environment where people feel heard and their opinions are valued. Inspires followership despite differing initial opinions. Teamwork and Collaboration Champions collaborations and connections across Maze. Establishes team norms and expectations. Seeks opportunities to spotlight team and individual contributions in public forums. Execution and Results Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success. Coaches others on resource management and work distribution/delegation. Aligns work to Maze's strategy, mission, and vision. Develop Others and Self Develops staff capabilities to handle delegation of responsibilities. Encourages staff to develop and execute personal stretch goals. Identifies and recommends ways to increase inclusive leadership.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at mazetherapeutics? Share your experience