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Medical Director, Clinical Development

Kailera Therapeutics

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Location:
United States, Waltham

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

205000.00 - 250000.00 USD / Year

Job Description:

We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.

Job Responsibility:

  • Responsible for medical monitoring/reporting and safety activities
  • Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
  • Acts as the medical contact at the company for clinical/medical issues
  • Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
  • Serve as the medical expert for assigned assets studies
  • Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
  • Collaborate and work 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 closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
  • Partner 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

Requirements:

  • 2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
  • Hands-on experience designing and executing clinical trials
  • Experience with IND submissions and global regulatory filings
  • Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
  • Excellent written and verbal communication skills, including protocol and regulatory document writing
  • Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
  • Can work independently
  • self-starter attitude
  • MD or equivalent is required

Nice to have:

  • Experience across multiple therapeutic areas, including obesity, is advantageous
  • Proven track record of contributing to BLA/NDA submissions is a strong plus
What we offer:
  • Comprehensive health benefits and tax-advantaged savings accounts
  • Flexible time off, 13 paid holidays, and a companywide year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Disability and life insurance

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:
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