Senior Medical Director, Clinical Development

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:

The applicant will work directly with SVP, Head of Clinical Development to design/conduct/disseminate data from clinical trials in patients with Diabetes and/or Obesity-related diseases. Clinical studies will range from Phase 1 to 3 and from single site to multi-site global pivotal trials. The applicant will also have an opportunity to participate in developing INDs and other global regulatory body interactions. In addition to hands-on clinical development work, the applicant will have the opportunity to grow and expand the clinical development team with additional hiring as needed.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Provide strategic and hands-on leadership in the design and execution of clinical development programs, with a primary focus on protocol development.
• Partner with cross-functional teams, including regulatory, biostatistics, clinical operations, and pharmacovigilance, to ensure protocols align with scientific, regulatory, and operational goals.
• Incorporate feedback from investigators, advisory boards, and regulatory bodies to refine and finalize study protocols.
• Lead the creation of clinical study protocols that are scientifically robust, operationally feasible, and aligned with the company’s strategic objectives.
• Ensure protocols are designed to address key clinical questions, regulatory requirements, and patient safety considerations.
• Collaborate with cross-functional teams to define study endpoints, inclusion/exclusion criteria, and other critical protocol components.
• Lead medical oversight of ongoing clinical trials, ensuring the highest standards of safety, integrity, and compliance.
• Act as a key medical representative during investigator meetings, providing expertise and guidance to ensure alignment across study teams and sites.
• Monitor trial progress, including patient safety, adverse events, and protocol adherence, providing actionable recommendations to address challenges as they arise.
• Actively participate in clinical study team meetings and provide expert medical guidance to support the successful execution of clinical trials.
• Partner with the safety team to oversee adverse event reporting, safety monitoring committees, and risk mitigation strategies.
• Contribute to regulatory submissions and interactions with worldwide regulatory bodies, including the preparation and review of INDs, NDAs, and BLAs.
• Collaborate with regulatory teams to address agency feedback, ensuring alignment with clinical development and regulatory strategies.
• Be prepared to contribute as a hands-on individual contributor, leading key aspects of clinical trial design and execution in a fast-paced, collaborative environment.
• As programs expand, there will be opportunities to manage and mentor team members, contributing to the growth and development of the clinical development function.
• Operate effectively in a dynamic startup environment, demonstrating a willingness to take on diverse responsibilities and adapt to evolving priorities.
• Play an instrumental role in building the company’s clinical development capabilities as the pipeline progresses.

Required Qualifications:

• 7+ years’ experience in clinical development, including protocol design, study conduct oversight, and cross-functional collaboration, is required.
• Strong understanding of the clinical trial process, including patient safety monitoring, regulatory requirements, and clinical data analysis.
• Clinical and/or drug development experience in diabetes or obesity-related diseases is strongly preferred, with familiarity in designing and managing trials in these therapeutic areas.
• Demonstrated ability to work effectively in a fast-paced, hands-on, cross-functional environment, balancing multiple priorities while maintaining high standards of quality and compliance.
• Exceptional teamwork, communication, and problem-solving skills, with a proven ability