Senior Medical Director, Pharmacovigilance

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.

Preferred 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 activities
• Maintain oversight of the safety governance framework including the timely escalation of medical safety issues
• Lead and actively collaborate with cross functional teams to ensure that safety considerations are integrated into clinical development and/or post-marketing activities as applicable
• Build, lead, and inspire a team of DSPV MDs and scientists
• Provide 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 modules
• Support labeling decisions and contribute to medical content of safety communications
• Oversee and actively contribute to safety signal detection and evaluation activities
• Collaborate cross functionally to utilize and optimize the safety signaling system including data visualization and analysis tools
• As applicable, contribute to publication strategy and ensure that safety data are accurately represented in scientific communications
• Represent DSPV on audits/inspections; provide and contribute to safety responses as needed
• Oversee and contribute to responses to deviations and CAPAs as related to medical safety or pharmacovigilance science
• Lead and actively contribute to the preparation and implementation of procedural documents as applicable to medical safety and pharmacovigilance
• Contribute as needed to the Global DSPV Business Continuity Plan
• Provide and oversee medical safety content for fit-to-purpose pharmacovigilance training to internal and external partners as needed
• Provide subject matter expertise for safety/technology strategies, design, implementation and enhancement of drug safety processes and systems
• Assist the SVP, Global DSPV with the planning and development of the overall pharmacovigilance team and function including departmental goals, organization, and budgeting
• Identify and implement innovative technical, procedural, or resourcing solutions to improve DSPV safety surveillance capabilities
• Other responsibilities as assigned

Required Qualifications:

• A minimum of 10 years of experience in global pharmacovigilance including at least 5 years in people leadership roles
• 2-5 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
• Working knowledge of relevant local and global regulatory requirements and guidance documents
• 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