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Kailera Therapeutics

Clinical-stage obesity and metabolic drugs developer

Medical Director - Clinical Development

Biology & BiotechConfirmed live in the last 24 hours
Full-timeRemote in USA

About the Job

Requirements

  • At least 2 years of industry experience in clinical development, preferably in a biotech or small pharmaceutical environment.
  • Hands-on experience designing and executing clinical trials.
  • Experience with regulatory submissions and global regulatory filings.
  • Understanding of Good Clinical Practice, clinical trial design, regulatory requirements, and safety monitoring.
  • Excellent written and verbal communication skills, including protocol and regulatory document writing.
  • Ability to engage with key opinion leaders, investigators, and cross-functional teams.
  • Ability to work independently.
  • MD or equivalent degree required.

Responsibilities

  • Responsible for medical monitoring, reporting, and safety activities.
  • Provide 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, and NDA submissions and briefing packages.
  • Collaborate with Clinical Operations on 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, and Translational Science teams.
  • Partner with external collaborators, key opinion leaders, contract research organizations, 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 across multiple therapeutic areas, including obesity, is advantageous.
  • A proven track record of contributing to BLA or NDA submissions is a strong plus.

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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