Senior Medical Director, Pharmacovigilance job at Kailera Therapeutics, Inc. in Waltham, MA, San Diego, CA

Title: Senior Medical Director, PharmacovigilanceLocation: Waltham, MassachusettsJob 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 Vice President, Global Drug Safety and Pharmacovigilance (DSPV), the Senior Medical Director will establish and maintain the strategic, scientific, and tactical oversight for medical safety evaluation and benefit-risk assessment globally for all Kailera products throughout their lifecycle with focus on patient well-being and compliance with applicable regulatory requirements.This individual will lead and collaborate cross functionally to identify and drive forward pharmacovigilance strategies and innovations that support Kailera’s mission. Required location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week). Responsibilities:Develop, lead, and oversee the benefit-risk assessment and safety surveillance activitiesMaintain oversight of the safety governance framework including the timely escalation of medical safety issuesLead and actively collaborate with cross functional teams to ensure that safety considerations are integrated into clinical development and/or post-marketing activities as applicableBuild, lead, and inspire a team of DSPV MDs and scientistsProvide and oversee input into the safety sections of clinical trial documents (e.g. IB, Protocols, ICFs, CSRs)Lead the preparation of the safety sections of regulatory submission modulesSupport labeling decisions and contribute to medical content of safety communicationsOversee and actively contribute to safety signal detection and evaluation activitiesCollaborate cross functionally to utilize and optimize the safety signaling system including data visualization and analysis toolsAs applicable, contribute to publication strategy and ensure that safety data are accurately represented in scientific communicationsRepresent DSPV on audits/inspections; provide and contribute to safety responses as neededOversee and contribute to responses to deviations and CAPAs as related to medical safety or pharmacovigilance scienceLead and actively contribute to the preparation and implementation of procedural documents as applicable to medical safety and pharmacovigilanceContribute as needed to the Global DSPV Business Continuity PlanProvide and oversee medical safety content for fit-to-purpose pharmacovigilance training to internal and external partners as neededProvide subject matter expertise for safety/technology strategies, design, implementation and enhancement of drug safety processes and systemsAssist the SVP, Global DSPV with the planning and development of the overall pharmacovigilance team and function including departmental goals, organization, and budgetingIdentify and implement innovative technical, procedural, or resourcing solutions to improve DSPV safety surveillance capabilitiesOther responsibilities as assigned Required Qualifications:A minimum of 10 years of experience in global pharmacovigilance including at least 5 years in people leadership roles2-5 years of experience in clinical practice or academic medicineProven experience in safety data analysis, signal management, and benefit-risk evaluationWorking 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 modelsProven experience with authoring or contributing to clinical study and regulatory submission documentsWorking knowledge of relevant local and global regulatory requirements and guidance documentsExperience in creating or managing working documents such as SOPs or Work InstructionsStrong ability to proactively identify risks and initiate/manage risk minimization activitiesStrong ability to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environmentStrong ability to prioritize, multitask, and deliver quality results that meet tight timelinesAbility to influence and keep teams focused and motivatedStrong 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 plusBenefits of Working at KaileraIn addition to traditional benefits, we provide enhanced offerings designed to support the well-being