Senior Director, Drug Safety Operations (remote)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

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.

Basic 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.

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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$160,500 - $259,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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