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Kailera Therapeutics

Clinical-stage obesity and metabolic drugs developer

Senior Medical Director - Clinical Development

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeWaltham, MA, USA

About the Job

Requirements

  • At least 4 years of industry experience in clinical development, preferably in a biotech or small pharma environment.
  • Hands-on experience designing and executing clinical trials.
  • Understanding of good clinical practice (GCP), clinical trial design, regulatory requirements, and safety monitoring.
  • Strong written and verbal communication skills, including protocol and regulatory document writing.
  • Ability to engage with key opinion leaders (KOLs), investigators, and cross-functional teams.
  • Ability to work independently.
  • Advanced PowerPoint skills and working knowledge of Excel and other commonly used clinical systems and tools.
  • Ability to manage multiple studies and deadlines in a fast-paced environment.
  • Exceptional attention to detail.
  • An MD or equivalent degree is required.

Responsibilities

  • Be responsible for medical monitoring, reporting, and safety activities.
  • Provide strategic medical leadership in designing, planning, and executing clinical development strategies across multiple studies.
  • Act as the company’s medical contact for clinical and medical issues.
  • Interpret, report, and prepare oral and written product research results in concert with senior clinical personnel.
  • Serve as the medical expert for assigned asset studies.
  • Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages.
  • Collaborate closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution.
  • Oversee and support data interpretation, analysis, and clinical study reports.
  • Work with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams.
  • Drive partnerships with external collaborators, KOLs, CROs, and investigators.
  • Support scientific publications, conference presentations, and other external communications.
  • Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting.

Desired Qualifications

  • Experience in the cardiometabolic therapeutic area.
  • A proven track record of contributing to IND submissions and global regulatory filings.

About the Company

Kailera Therapeutics

Clinical-stage obesity and metabolic drugs developer

Kailera Therapeutics focuses on obesity and related metabolic conditions by acquiring and developing clinical-stage drug candidates and moving them toward commercialization. Its lead asset, KAI-9531, is an injectable dual agonist of GLP-1 and GIP receptors for obesity and type 2 diabetes, and the pipeline includes an oral GLP-1 agonist (KAI-7535), an oral tablet form of KAI-9531, and an injectable tri-agonist targeting GLP-1, GIP, and glucagon receptors (KAI-4729). The company differentiates itself by sourcing assets outside of early research, pursuing a mix of injectable and oral therapies, and leveraging a high-profile leadership team and substantial funding to progress a broad portfolio under external licenses. Kailera’s goal is to advance multiple metabolic disease therapies from clinical development toward commercialization to improve outcomes for patients with obesity and related conditions.

Company size
51-200
Company stage
IPO
Headquarters
Waltham, MA
Founded
2024

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