Senior Director, Clinical Pharmacology

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.

The Senior Director, Clinical Pharmacology will report to the Vice President, Translational Medicine and will be responsible for the design, execution, and interpretation of clinical pharmacology studies and strategy to support development programs in patients with obesity-related diseases. The Senior Director, Clinical Pharmacology requires strong scientific, technical, and leadership skills to develop and implement clinical pharmacology strategies to advance drug candidates across various stages of development.

Working closely with cross-functional partners, the individual is responsible for providing strategic and technical subject matter expertise and scientific oversight for the clinical pharmacology support of Kailera’s therapeutic candidates.

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

• Develop, implement, and/or supervise clinical pharmacology strategies to drive Kailera’s programs through all the stages, from research to Phase 3
• Serve as the clinical pharmacology lead on project teams, providing subject matter expertise
• Work collaboratively with functional partners, including clinical development, biostatistics, translational medicine, CMC, toxicology, clinical operations, and regulatory to deliver project and corporate objectives
• Ensure robust development and alignment of clinical pharmacology strategies with the therapeutic indication, patient population, and development phase
• Advocate and represent clinical pharmacology, PK/PD, and model-informed drug development
• Develop the clinical pharmacology package, including dose selection and optimization
• Contribute to the development of regulatory documents (e.g. clinical protocols, INDs, NDAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions
• Build a culture of collaboration, innovation, and accountability within the team
• Partner with translational medicine colleagues to integrate clinical pharmacology strategy into broader translational, platform, and clinical development strategies

• 10+ years of experience in clinical pharmacology in the biotech or pharmaceutical industry
• Proven track record of supporting drug candidates at various stages of development within the clinical pharmacology function
• Strong expertise in pharmacokinetics, pharmacodynamics, and model-informed drug development strategies
• Comprehensive knowledge of global regulatory requirements for clinical pharmacology and experience contributing to regulatory submissions (IND, NDA, BLA)
• Prior experience in diabetes, obesity, or related metabolic diseases is highly preferred
• Excellent leadership and cross-functional collaboration skills, with the ability to influence and drive strategy across teams
• Exceptional written and verbal communication skills, including the ability to convey complex scientific concepts to diverse stakeholders

• Submission of IND/NDA/BLA and global marketing applications
• Experience leading regulatory interactions related to clinical pharmacology strategies
• Expertise in diabetes, weight management, or related metabolic diseases

• PhD or Pharm
  
  D in a relevant scientific discipline (e.g. clinical pharmacology)

$241,000—$295,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a…