Associate Director, Clinical Drug Safety

Eli Lilly and Company; Boston (MA); A distancia; USD 117.000 - 189.000; Jornada completa

Descripción de la vacante

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director, Clinical Drug Safety to lead pharmacovigilance activities across its clinical programs. Based remotely in the US with limited travel to Boston, the role will oversee signal detection, DSUR planning, ICSR evaluation, and regulatory submissions, ensuring high-quality safety deliverables.

You will collaborate with cross-functional teams and external vendors to maintain inspection-ready processes,

Formación

• RN, PharmD, or equivalent by degree
• 6+ years in drug safety with 3+ years pharmacovigilance compliance
• Experience in signal identification and escalation
• Experience with safety data analysis and DSURs
• Knowledge of global drug safety regulations
• Experience leading cross-functional safety activities

Responsabilidades

• Signal detection and management across Drug Safety
• Aggregate reports support including DSURs
• Safety science input to protocols and regulatory submissions
• Lead safety governance and cross-functional study teams
• ICSR review and regulatory reporting oversight
• Ensure compliance with evolving safety regulations

Conocimientos

Pharmacovigilance

Signal detection

DSUR preparation

ICSR evaluation

Regulatory submissions

Cross-functional leadership

Literature surveillance

Safety governance

Data analysis

Global regulations

Educación

RN/PhD/PharmD/MS/BS in health sciences

Descripción del empleo

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.

Organization And Position 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.
We are seeking an Associate Director, Clinical Drug Safety, to support pharmacovigilance activities across Centessa’s clinical-stage development programs. Reporting to Centessa’s Executive Director - Safety Science, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance activities such as signal management, serve as key analytic and safety support for regulatory compliance/program execution and support overseeing aggregate reports production and literature review. The Associate Director will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready processes in a fast-paced, development-focused environment.

Responsibilities

• Signal Detection and Management
  • Support the implementation of signal identification and management strategy, coordinating discussions within the Drug Safety team and cross‑functional partners.
  • Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational products.
  • Review adverse event data and other safety-related data for signal detection activities.
  • Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings as appropriate.
  • Responsible for signaling review and the coordination of signal review activities with Drug Safety and cross-functional teams.
  • Support in the preparation of safety governance slides and documentation of meeting minutes.
• Aggregate reports support
  • Provide scientific input into the preparation and review of aggregate reports such as DSURs and line listings.
  • Oversee DSUR strategy, preparation and adherence to timelines with key cross-functional partners and vendor.
  • Demonstrate effective skills with cross-functional partners to ensure that safety data authorship for aggregate reports such as DSUR are high quality.
• Safety Scientist support during all phases of product development
  • Provide scientific input into the preparation and review of safety‑related sections of protocols, Investigator’s Brochures, and regulatory submissions.
  • Serve as the lead drug safety representative on cross‑functional study teams and in collaboration with senior Drug Safety team, shaping safety strategy, influencing program decision‑making, and advising on safety issue management.
  • Maintain expert‑level knowledge of therapeutic areas and evolving global drug safety regulations, guidelines and best practices, and apply this expertise to support program decision making and safety governance.
  • Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.
• ICSR support
  • Ensure the scientific integrity and quality of safety data through expert review of complex cases.
  • Contribute to case narratives and guide the scientific preparation of regulatory‑ready case submissions, including SUSARs, in alignment with global reporting requirements.
  • Oversee vendor‑led ICSR and clinical trial SAE evaluations, ensuring medical accuracy, regulatory reportability, and global consistency through scientific review and quality governance.
  • Lead or contribute to complex, cross‑functional safety projects, safety signal evaluations, and ad‑hoc scientific analyses to support portfolio needs and organizational priorities.
• Departmental Compliance
  • Ensure drug safety activities remain complaint with evolving regulations.
  • Supporting and assisting in the implementation, execution and maintenance of safety processes.
  • Support initiatives to initiatives for process improvement and consistency.
    

Basic Qualifications

• RN, PhD, PharmD, MS, BS degree in health sciences or related field required.
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.
• In‑depth knowledge of safety signal identification, evaluation, and escalation processes, including application of governance frameworks and contribution to labeling updates.
• Demonstrated capability in aggregate safety data analysis, ongoing safety surveillance, and risk–benefit assessment for investigational products.
• Experience overseeing and interpreting medical literature surveillance to identify emerging safety information and assess clinical relevance.
• Strong expertise in scientific review and preparation of safety deliverables, including DSURs, line listings, aggregate safety summaries, Investigator’s Brochures, protocols, and regulatory submissions.
• Advanced knowledge of global drug safety/pharmacovigilance regulations, guidelines, and best practices and their application to safety decision making.
• Hands‑on scientific expertise in ICSR and clinical trial SAE assessment, including causality, seriousness, expectedness, and regulatory reportability, with experience guiding SUSAR preparation.
• Proven ability to provide scientific and quality oversight of vendor‑led safety activities, ensuring accuracy, consistency, and regulatory compliance.
• Technical proficiency serving as a drug safety subject matter expert on cross‑functional teams, contributing to safety strategy, complex safety evaluations, and ad hoc scientific analyses.
  

Additional Preferences

• Advanced Degree (PharmD, PhD strongly preferred).
• CNS experience preferred.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communicator who works effectively in small, cross-functional teams.
  

Work Location

Remote-based in the US, with <10% travel to headquarters in Boston, MA.
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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
$117,000 - $189,200
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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