Senior Director, Clinical Development (MD)

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:

We are an innovative, fast-paced, and rapidly growing late-stage pharmaceutical company seeking a Senior Medical Director to lead the medical monitoring activities of a pivotal global clinical trial. This is a high-impact and high visibility role with broad responsibilities spanning clinical development, regulatory engagement, and key opinion leader (KOL) interactions. The ideal candidate is an experienced physician with strong leadership, strategic vision, and deep knowledge in clinical research.

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

Responsibilities:

• Provide medical monitoring oversight for a large, late-stage clinical trial, ensuring patient safety and data integrity.
• Lead clinical development strategy, working cross-functionally to ensure alignment with regulatory and corporate goals.
• Collaborate with regulatory affairs to contribute to regulatory submissions, and regulatory interactions.
• Work closely with clinical operations, biostatistics, data management, pharmacovigilance to support trial execution and data analysis.
• Develop and review all study materials, including protocols, protocol supplements investigator brochures, informed consent documents, and clinical study reports.
• Serve as a key company representative in external interactions with KOLs, investigators, regulatory agencies, and advisory boards.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
• Provide clinical and scientific leadership to cross-functional teams, including clinical operations, medical affairs, commercial, etc.
• Mentor and develop junior medical staff, fostering a culture of scientific excellence and collaboration.
• Travel approximately once per month or less for investigator meetings, scientific conferences, and regulatory interactions.

Required Qualifications:

• 5+ years of experience in clinical development programs in the biotechnology/pharmaceutical industry.
• Prior experience with medical monitoring.
• Strong understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring.
• Experience working with regulatory agencies (FDA, EMA, etc.) on clinical development programs.
• Excellent written and verbal communication skills, including protocol and regulatory document writing.
• Demonstrated ability to engage with KOLs, investigators, and cross-functional teams.
• Strong leadership, team-building, and decision-making skills.
• Can work independently, self-starter attitude.

Preferred Qualifications:

• Experience in diabetes or obesity-related diseases is strongly preferred, with familiarity in designing and managing trials in these therapeutic areas.

Education:

• MD degree with strong clinical experience; board certification preferred.

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:

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