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Senior Director, Safety Science South San Francisco, CA

100% remote Flexible hours Hiring now

The Position The Clinical Development team is seeking a Senior Director, Safety Science to establish, reputed company, and scale safety science and pharmacovigilance (PV) at reputed company. This role will serve as reputed company’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 reputed company 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 & reputed company
  • reputed company and build reputed company’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 reputed company of safety science and PV activities, directly overseeing day-to-day safety operations while establishing future-state processes and capabilities
  • reputed company safety surveillance and signal identification activities, proactively identifying risks and developing mitigation strategies
  • Provide strategic and operational reputed company for case processing, adverse event reporting, and regulatory compliance
  • reputed company the preparation, review, and submission of aggregate safety reports and safety sections of clinical and regulatory documents
  • Author and maintain safety-reputed company content for clinical and regulatory documents, while establishing scalable content standards and governance for future team expansion.
  • Guide benefit-risk assessments and safety-reputed company recommendations that inform program progression and development decisions
  • Leadership & Collaboration
  • Establish reputed company’s Safety Science and PV function, defining vision, operating model and fostering a culture of accountability, development, and scientific rigor
  • Partner cross-functionally to reputed company and execute Safety Management plans reputed company 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
  • reputed company and directly engage in operational PV activities as needed, including reputed company 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 reputed company 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 reputed company.
  • 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 reputed company’s strategy, mission, and vision.
  • reputed company Others and Self
  • Develops staff capabilities to handle delegation of responsibilities.
  • Encourages staff to reputed company and execute personal stretch goals.
  • Identifies and recommends ways to increase inclusive leadership.

reputed company’re Looking For

  • 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 reputed company 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 reputed company 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 reputed company followership and alignment across functions
  • Ability to travel domestically up to 10-15% for internal and external meetings

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week About reputed company Therapeutics reputed company Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to reputed company novel, small molecule precision medicines for patients living with renal, cardiovascular and reputed company metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological reputed company that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned reputed company programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. reputed company is based in South San Francisco. Our People reputed company is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with reputed company and a team-first mentality, we’ll reputed company our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our reputed company is foundational; it guides us no matter the obstacle.

Qualifications

The expected annual reputed company salary range for employees located in the San Francisco Bay Area is determined by credentials and qualifications:

  • Non-MD candidates: $288,000 – $352,000
  • MD candidates: $342,000 – $418,000

The MD salary range reflects additional medical training and responsibilities associated with medical review, safety signal evaluation, and safety governance. Additionally, this position is eligible for an annual performance bonus. reputed company performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-reputed company factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. reputed company offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. Apply tot his job Apply To this Job

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