Associate Director, Clinical Drug Safety

Lilly; Boston (MA); Remote; USD 117,000 - 189,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical, dental, vision benefits

Well-being programs

Job summary

Lilly is seeking a remote-based Senior Drug Safety Scientist in the US with extensive pharmacovigilance experience. You will lead signal detection, oversee DSURs and literature surveillance, and collaborate across clinical development, regulatory, and QA to ensure safety governance and regulatory compliance.

Role involves cross‑functional study team collaboration, expert ICSR review, and strategic input on safety sections of regulatory submissions.

Qualifications

• RN/PhD/PharmD/MS/BS in health sciences or related field required.
• 6+ years in drug safety in biotech/pharma with 3+ years pharmacovigilance compliance.
• Experience with safety signal evaluation, governance and labeling updates.
• Strong capability in safety data analysis and risk–benefit assessment.

Responsibilities

• Signal detection and management within Drug Safety and cross‑functional teams.
• Analyze aggregate safety data; identify emerging signals; support risk‑benefit assessments.
• Review adverse event data for signal detection; oversee literature surveillance.
• Coordinate DSURs, line listings, safety summaries; ensure timely governance reviews.
• Provide scientific input for protocols, ICH reports, and regulatory submissions.
• Lead cross‑functional safety projects; mentor vendor safety activities; ensure compliance.

Skills

Signal detection

Literature surveillance

DSUR preparation

Aggregate safety data

Regulatory submissions

Education

Health sciences degree

Job description

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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.

#WeAreLilly