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Kailera Therapeutics · 2 days ago

Senior Director, Clinical Pharmacology

Greater Boston

Full-time

Hybrid

Director/Executive

$210K/yr - $270K/yr

10+ years exp

Kailera Therapeutics is committed to developing therapies that empower individuals to transform their lives and health. The Senior Director, Clinical Pharmacology will lead the design and execution of clinical pharmacology studies to support development programs for obesity-related diseases, providing strategic and technical expertise across various stages of drug development.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Clinical pharmacologyPharmacokineticsPharmacodynamicsModel-informed drug developmentRegulatory submissionsLeadership skillsCross-functional collaborationTeam culture buildingScientific oversightExperience in diabetesExperience in obesityCommunication skills

Required

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

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