Kailera is seeking a Senior Director, Clinical Pharmacology to lead the design, execution, and interpretation of clinical pharmacology studies for obesity-related diseases. This role involves developing and implementing strategies across all development stages, providing scientific oversight, and collaborating with cross-functional partners. The ideal candidate will possess strong scientific, technical, and leadership skills to advance drug candidates and contribute to regulatory documents, fostering a culture of innovation and accountability.

Must Have

• Develop and supervise clinical pharmacology strategies
• Lead clinical pharmacology on project teams
• Collaborate with cross-functional partners
• Align clinical pharmacology strategies with development phases
• Represent clinical pharmacology, PK/PD, and model-informed drug development
• Develop clinical pharmacology package, including dose selection
• Contribute to regulatory documents (protocols, INDs, NDAs)
• Represent clinical pharmacology in regulatory interactions
• Foster collaboration, innovation, and accountability
• Integrate clinical pharmacology into broader development strategies
• 10+ years clinical pharmacology experience in biotech/pharma
• Track record supporting drug candidates in clinical pharmacology
• Expertise in pharmacokinetics, pharmacodynamics, model-informed drug development
• Knowledge of global regulatory requirements for clinical pharmacology
• Experience contributing to regulatory submissions (IND, NDA, BLA)
• Strong leadership and cross-functional collaboration skills
• Exceptional written and verbal communication skills
• PhD or PharmD in clinical pharmacology or related discipline

Good to Have

• Experience in diabetes, obesity, or metabolic diseases
• Submission of global marketing applications
• Leading regulatory interactions for clinical pharmacology
• Expertise in diabetes, weight management, or metabolic diseases

Perks & Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

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 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)

Responsibilities:

• 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

Required Qualifications:

• 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)
• 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:

• 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

Education:

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

Salary Range

$210,000 - $270,000 USD

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 year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

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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