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.

What You’ll Do:

The Senior Director, Clinical Pharmacology at Kailera Therapeutics will report to the VP of Translational Medicine and will be responsible for the strategic design, execution, and interpretation of clinical pharmacology studies to support the development of novel therapies for diabetes and obesity-related diseases. This role requires a deep understanding of clinical pharmacology principles, pharmacokinetics (PK), pharmacodynamics (PD), and model-informed drug development to advance Kailera’s pipeline from early research through Phase 3 clinical trials. The Senior Director will collaborate cross-functionally to develop and implement clinical pharmacology strategies that optimize dose selection, enhance drug efficacy and safety profiles, and ensure regulatory compliance.

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

Responsibilities:

• Lead the development and execution of clinical pharmacology strategies to support Kailera’s therapeutic programs from early-stage research through late-stage clinical development.
• Serve as the clinical pharmacology lead on multiple project teams, providing scientific and strategic expertise to guide decision-making.
• Collaborate with Clinical Development, Biostatistics, Translational Medicine, CMC, Toxicology, Clinical Operations, and Regulatory Affairs to align clinical pharmacology strategies with overall program objectives.
• Drive dose selection and optimization strategies using model-informed drug development (MIDD) approaches.
• Develop and oversee the clinical pharmacology package, including PK/PD assessments and immunogenicity evaluation.
• Represent clinical pharmacology in regulatory submissions, including authoring relevant sections of INDs, NDAs, and BLAs, and actively participate in interactions with global regulatory agencies.
• Stay at the forefront of regulatory and scientific advancements in clinical pharmacology, PK/PD modeling, and emerging methodologies.
• Build and foster a culture of collaboration, innovation, and accountability within the clinical pharmacology function.
• Partner with Translational Medicine colleagues to integrate clinical pharmacology insights into broader platform and clinical development strategies.

Required Qualifications:

• 10+ years of experience in clinical pharmacology within the biotech or pharmaceutical industry.
• Proven track record of supporting drug candidates across multiple stages of development.
• 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.

Preferred Qualifications:

• Hands-on experience with population PK/PD modeling and simulation tools.
• Experience leading regulatory interactions related to clinical pharmacology strategies.
• Knowledge of the incretin and cardiometabolic space, particularly GLP-1 receptor agonists.

Education:

• PhD or PharmD in Clinical Pharmacology, Pharmacokinetics, or a related scientific discipline.

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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