Medical Director, Pharmacovigilance - Waltham

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...

Job description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You'll Do:

Reporting to the Senior Medical Director, Global Patient Safety and Pharmacovigilance (DSPV), the Medical Director will provide strategic, scientific, and tactical leadership for global medical safety evaluation and benefit-risk management for assigned Kailera products throughout their lifecycle with focus on patient well-being and compliance with applicable regulatory requirements.

This role is instrumental in ensuring patient safety, regulatory compliance, and robust characterization of benefit-risk in both clinical development and real-world use, including shaping risk-management strategies, integrated evidence generation planning, and real-world evidence approaches. 

The medical director will collaborate extensively across and within their own function to advance Kailera's pharmacovigilance strategy to support the company's evolving pipeline, innovation, and mission. 

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

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

Required Qualifications:

• 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 Qualifications:

• Experience in pharmacoepidemiology, data science, or medical affairs is a plus

Education:

• MD, DO or equivalent medical degree required. Ph.D. degree is a plus

Salary Range $254,000—$305,000 USD

For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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