[Hiring] Senior Director, Drug Safety Operations @Lilly

Role Description

We are seeking a highly experienced and detail-oriented Senior Director, Drug Safety Operations to lead and optimize the operational aspects of our global safety and pharmacovigilance (PV) function. Reporting to the AVP, Drug Safety & Pharmacovigilance, this role will provide strategic and operational leadership for our global drug safety and pharmacovigilance function. This role is responsible for overseeing end-to-end safety operations, including:

• Case processing
• Individual case safety report (ICSR) management
• Regulatory reporting
• Vendor oversight
• Inspection readiness
• Compliance with global pharmacovigilance requirements across the product lifecycle

The Senior Director will lead the development and optimization of scalable processes, systems, and partnerships that ensure high-quality, efficient, and compliant safety reporting while supporting Centessa's growing portfolio. Operating in a dynamic environment, this individual will drive operational excellence, continuous improvement, and innovation to advance patient safety and regulatory compliance globally.

Responsibilities

• Lead Drug Safety Operations activities and manage assigned team members, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of safety information across clinical development programs.
• Partner across the Drug Safety leadership team to implement and enhance operational processes, governance activities, and resourcing plans in support of an evolving development portfolio.
• Lead execution of the global Drug Safety Operations strategy, operating model, governance framework, objectives, and resourcing plans to support an evolving portfolio and business priorities.
• Oversee pharmacovigilance operations, including case intake, triage, processing, medical coding, quality review, Individual Case Safety Reports (ICSRs), SUSAR reporting, and submissions to global regulatory authorities.
• Lead oversight and governance of pharmacovigilance vendors, CROs, safety database providers, and other external partners, ensuring high-quality service delivery, regulatory compliance, performance management, and financial stewardship.
• Establish, maintain, and continuously improve pharmacovigilance processes, SOPs, work instructions, quality systems, and operational controls to ensure compliance with global regulations and industry standards, including FDA, EMA, MHRA, PMDA, and ICH requirements.
• Ensure ongoing inspection readiness and lead operational support for regulatory inspections, partner audits, and quality assessments, including CAPA development and implementation as needed.
• Monitor operational performance through KPIs, quality metrics, dashboards, and trend analyses to drive data-informed decision-making, accountability, and continuous improvement.
• Partner cross-functionally with Drug Safety physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biometrics, and external partners to align pharmacovigilance operations with program and corporate objectives.
• Support the preparation and operational execution of aggregate safety reporting activities, including DSURs, PBRERs, Risk Management Plans, and other regulatory deliverables, ensuring data integrity and inspection-ready documentation.
• Drive operational excellence through process optimization, system enhancements, automation, and scalable solutions that improve efficiency, quality, compliance, and organizational effectiveness.
• Build, develop, and mentor a high-performing Drug Safety Operations team while fostering a culture of accountability, collaboration, innovation, and patient focus.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related scientific discipline.
• 10+ years of pharmacovigilance and drug safety operations experience within the biotechnology and/or pharmaceutical industry, including increasing levels of responsibility.
• Experience supporting small molecule development programs and/or neuroscience/CNS products within an emerging biotechnology environment strongly preferred.
• Demonstrated experience managing global safety operations, including case processing, Individual Case Safety Reports (ICSRs), SUSAR reporting, and regulatory submissions within a GxP-regulated environment.
• Strong knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, MHRA, ICH, GVP, and applicable international reporting requirements.
• Experience overseeing pharmacovigilance vendors, CROs, and external service providers, including performance management, governance, and compliance oversight.
• Hands-on experience with safety databases and pharmacovigilance technologies (e.g., Argus, ArisG, or comparable systems), including familiarity with MedDRA, WHO Drug dictionaries, and E2B(R3) reporting standards.
• Experience supporting clinical-stage development programs, with knowledge of aggregate safety reporting activities such as DSURs, PBRERs, Risk Management Plans, and related regulatory deliverables.
• Proven ability to lead and develop staff, manage competing priorities, and operate effectively in a fast-paced, evolving biotech environment.
• Strong cross-functional collaboration, communication, and stakeholder management skills, with the ability to work effectively across geographies and organizational levels.
• Experience supporting regulatory inspections, audits, and health authority interactions, with a demonstrated commitment to quality, compliance, and patient safety.

Preferred Qualifications

• Advanced degree (e.g., PharmD, MSN, MPH, or MS) in a related scientific discipline.

Work Location

The Senior Director, Drug Safety Operations role is a remote position based in the US, with occasional travel.

Benefits

• Eligibility to participate in a company-sponsored 401(k); pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).