Senior Vice President, Clinical Development

What You’ll Do:

This is a critical leadership role within the medical organization. The Head of Clinical Development leads the development, execution, and communication of the global medical and scientific evidence generation strategy for our products. They solicit and incorporate cross-functional input into this strategy, translate it into an aligned vision and actionable global development plan, and are accountable for its execution. They develop key external scientific relationships with leaders in the obesity research and medical community, interact with global regulatory authorities, and work cross-functionally within the medical organization and throughout Kailera.

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

Responsibilities:

• Build, grow, and lead the global clinical development organization
• Develop and execute global development strategy and resultant evidence generation plan with incorporation of cross-functional and regional input
• Design, execute, complete, and communicate clinical trials (eg, scientific advisory boards, protocol development, regulatory and ethic committee interactions, medical monitoring, data analyses, study reports, regulatory correspondences and filings, presentations, and data dissemination)
• Deliver robust clinical trial data on-time and on-budget to inform product benefit: risk
• Interface with global medical opinion leaders in obesity to inform clinical development program and maintain engagement
• Clear, data-based, patient-focused communications with global regulators
• Provide clinical input to regulatory, safety, medical affairs, commercial, payer, and manufacturing colleagues

Qualifications:

• At least 15 years of clinical development experience with proven track record of executing clinical trials and global regulatory interactions
• Significant late-stage development experience across large-scale, complex programs
• Experience in obesity and/or metabolic disease strongly preferred
• Exceptional cross-functional communication skills, with the ability to influence and lead across diverse stakeholders
• Prior leadership, budgeting and resource management experience required
• Uncompromising ethics, passion for teamwork and people, attention to detail, solution focus, and strong communication skills
• Ability and willingness to fly at necessary altitude to get job done
• A drive for problem solving, continual learning, and attracting, mentoring, and retaining best people
• Local candidates are strongly preferred; relocation and remote talent will be considered. Remote employees must adhere to the Hub & Home working model, including a minimum of one week per month in the Waltham, MA corporate office (in addition to any other work-related travel), with overall work-related travel estimated at least 25%.

Education:

• MD or equivalent