Kailera Therapeutics · 5 days ago
Medical Director, Pharmacovigilance
Waltham, Massachusetts
Full-time
Hybrid
Director/Executive
$205K/yr - $250K/yr
8+ years expKailera is committed to developing therapies that empower individuals to transform their lives and enhance their health. The Medical Director will lead global medical safety evaluation and benefit-risk management for Kailera products, ensuring patient safety and regulatory compliance throughout the product lifecycle.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Provide expert medical interpretation of safety data from all sources (clinical, post-marketing, literature, and RWE) and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database
Oversee and execute safety signal detection and evaluation activities, ensuring timely, scientifically sound assessments and the optimization of signaling systems through data visualization and analysis tools
Incorporate insights from real-world data (EHRs, claims, registries) into surveillance and benefit-risk assessments to support evidence-generation strategies
Lead the development and oversight of global benefit-risk assessments and safety surveillance for clinical development programs and post-marketing phases
Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies, ensuring proactive identification and mitigation of safety risks
Lead the authoring and medical review of safety sections for regulatory documents (IBs, Protocols, DSURs, PSUR/PBRERs, and RMPs) and safety modules for marketing applications
Support labeling decisions and contribute medical expertise to safety communications, risk materials, and scientific publications
Collaborate with cross-functional stakeholders to integrate safety considerations into clinical development, post-marketing activities, and evidence-generation strategies
Lead and inspire a team of PSPV MDs, scientists, and operational colleagues, fostering a culture of accountability, scientific excellence, and collaboration
Partner with senior leadership (SVP/Medical Director) on departmental goals, organizational design, budgeting, and long-term pharmacovigilance planning
Act as a Subject Matter Expert (SME) for safety technology strategies, identifying innovative technical or resourcing solutions to improve DSPV surveillance capabilities
Contribute to the design, implementation, and enhancement of drug safety processes and systems to ensure high-performance PV operations
Maintain the medical safety governance framework, ensuring the timely identification, assessment, and escalation of significant safety issues
Represent the PSPV function during audits and inspections, leading the preparation of responses and managing deviations or CAPAs related to medical safety science
Drive the development of SOPs, work instructions, and "fit-to-purpose" pharmacovigilance training for internal and external partners
Qualification
Required
8+ years of experience in global pharmacovigilance
2+ years of experience in clinical practice or academic medicine
Proven experience in safety data analysis, signal management, and benefit-risk evaluation
Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
Demonstrated ability to develop and implement drug safety strategies, risk management plans, and safety governance models
Proven experience with authoring or contributing to clinical study and regulatory submission documents
Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Experience in creating or managing working documents such as SOPs or Work Instructions
Strong ability to proactively identify risks and initiate/manage risk minimization activities
Strong ability to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
Strong ability to prioritize, multitask, and deliver quality results that meet tight timelines
Ability to influence and keep teams focused and motivated
Strong ability to communicate complex issues clearly
Preferred
Experience in pharmacoepidemiology, data science, or medical affairs is a plus
Benefits
Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities
Equity grants
Company
Kailera Therapeutics
Kailera Therapeutics develops next-generation injectable and oral therapies for chronic weight management.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$1BKey Investors
Bain Capital Private Equity
2025-10-14Series B· $600M
2024-10-01Series A· $400M
Leadership Team
Ronald Renaud
President & CEO
Paul Burgess
Chief Operating Officer and Chief Business Officer
Recent News
Boston Globe
2026-01-16
2026-01-05
Company data provided by crunchbase