Senior Director, Drug Safety Operations (remote)

Lilly • Indianapolis, IN

6d • $160,500 - $259,600 • Remote

About The Position

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists for narcolepsy and potentially other sleep-wake disorders. The Senior Director, Drug Safety Operations will lead and optimize the operational aspects of the global safety and pharmacovigilance function, providing strategic and operational leadership across the product lifecycle. Reporting to the AVP, Drug Safety & Pharmacovigilance, the role oversees end-to-end safety operations, including case processing, ICSR management, regulatory reporting, vendor oversight, inspection readiness, and compliance with global pharmacovigilance requirements.

The role leads the development and optimization of scalable processes, systems, and partnerships to support high-quality, efficient, and compliant safety reporting across Centessa’s evolving portfolio. It drives operational excellence, continuous improvement, and innovation while supporting patient safety and global regulatory compliance. This is a US-based remote position with occasional travel.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related scientific discipline.
• 10 or more years of pharmacovigilance and drug safety operations experience in the biotechnology and/or pharmaceutical industry, with increasing levels of responsibility.
• Demonstrated experience managing global safety operations, including case processing, ICSRs, SUSAR reporting, and regulatory submissions in 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, such as Argus, ArisG, or comparable systems; familiarity with MedDRA, WHO Drug dictionaries, and E2B(R3) reporting standards.
• Experience supporting clinical-stage development programs and aggregate safety reporting, including DSURs, PBRERs, Risk Management Plans, and related regulatory deliverables.
• Proven ability to lead and develop staff, manage competing priorities, and work effectively in a fast-paced, evolving biotech environment.
• Strong cross-functional collaboration, communication, and stakeholder management skills, including ability to work across geographies and organizational levels.
• Experience supporting regulatory inspections, audits, and health authority interactions, with commitment to quality, compliance, and patient safety.

Nice To Haves

• Experience supporting small molecule development programs and/or neuroscience/CNS products within an emerging biotechnology environment.
• Advanced degree (e.g., PharmD, MSN, MPH, or MS) in a related scientific discipline.

Responsibilities

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

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior