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 :

Education :

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range

210,000-$270,000 USD

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION :

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify :

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

LI-Hybrid

Salary : $210,000 - $270,000