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

What You’ll Do:

The Patient Safety and Pharmacovigilance Intern (PSPV Intern) will report directly to the Senior Director, PV Operations and will work with PSPV and cross-functionally. This individual will be responsible for assisting members of the PSPV team with a variety of day-to-day tasks and support key PSPV projects/initiatives including safety vendor management, safety database oversight, ICSR review, signal detection and literature assessments, support projects, and participate in team activities.

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

Responsibilities:

• Research and understand the disease, symptoms, and treatment under investigation
• Participate in safety data analysis/signal detection (ICSR and aggregate data review)
• Understand the process of vendor management
• Review applicable Health Authority regulations and ICH guidelines to develop working knowledge of PSPV reporting obligations to ensure patient safety
• Lead a defined project (e.g. process optimization, data visualization, or data analytics) and prepare a final presentation for department and company leadership
• Opportunity to support PSPV projects

Required Qualifications:

• Proactive, engaged, eager and willing to learn approach to work
• Support and be part of the Kailera core values: Courageous, Collaborative, Compassionate, and Committed
• Excellent oral and written communication skills
• Interest and/or experience in drug safety and pharmacovigilance a plus
• Ability to work well in a fast-paced team environment

Education:

• Bachelor’s degree candidates who have completed two or more years and are pursuing a degree in life sciences (nursing, neuroscience, psychology, psychiatry, biology, pharmacy