Medical Director - Pharmacovigilance

1w1 week ago

Kailera Therapeutics, Inc.

Waltham, US · Full-time · $254,000 – $305,000

About this role

At Kailera Therapeutics, we are bold, authentic, and committed to developing therapies that transform lives and elevate health for obesity and related conditions. Rooted in entrepreneurial spirit and team-oriented culture, the Medical Director reports to the Senior Medical Director, Global Patient Safety and Pharmacovigilance. This role delivers strategic, scientific leadership for global medical safety evaluation and benefit-risk management across product lifecycles.

Provide expert medical interpretation of safety data from clinical trials, post-marketing, literature, and real-world evidence sources. Perform medical review of Individual Case Safety Reports within the ARGUS database. Oversee signal detection and evaluation using data visualization and analysis tools for timely assessments.

Incorporate real-world data from EHRs, claims, and registries into surveillance and benefit-risk strategies. Collaborate extensively across functions to integrate safety into clinical development and evidence generation. Lead a team of PSPV MDs, scientists, and operational colleagues, fostering accountability and excellence.

Partner with senior leadership on departmental goals, budgeting, and pharmacovigilance planning. Act as SME for safety technology strategies and process enhancements. Hub-based in Waltham, MA, onsite 3-4 days per week, advancing Kailera’s innovative pipeline.

Requirements

MD or equivalent medical degree with pharmacovigilance expertise
Proficiency in medical review of ICSRs and safety databases like ARGUS
Experience in safety signal detection and benefit-risk evaluation
Knowledge of global regulatory requirements for pharmacovigilance (FDA, EMA)
Familiarity with real-world evidence sources (EHRs, claims, registries)
Leadership in Risk Management Plans (RMPs) and safety surveillance
Ability to author safety sections for DSURs, PSURs, and regulatory submissions
Cross-functional collaboration in clinical development and post-marketing

Responsibilities

Provide expert medical interpretation of safety data from all sources and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database
Oversee and execute safety signal detection and evaluation activities using data visualization and analysis tools
Incorporate insights from real-world data (EHRs, claims, registries) into surveillance and benefit-risk assessments
Lead development and oversight of global benefit-risk assessments and safety surveillance for clinical and post-marketing phases
Drive lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies
Lead authoring and medical review of safety sections for regulatory documents (IBs, Protocols, DSURs, PSUR/PBRERs, RMPs)
Collaborate with cross-functional stakeholders to integrate safety into development and evidence-generation strategies
Lead and inspire a team of PSPV MDs, scientists, and operational colleagues