Kailera

Medical Director, Clinical Development

US-Remote. Posted 2 months ago

The role

This person will design and execute clinical development programs to advance a pipeline of therapeutics for obesity and related conditions. They will provide medical leadership, monitor safety, and collaborate with cross-functional teams and external partners.

What you will do

  • Responsible for medical monitoring/reporting and safety activities
  • Provide medical leadership in the design, planning, and execution of clinical development strategies
  • Acts as the medical contact at the company for clinical/medical issues
  • Interprets, reports, and prepares oral and written results of product research
  • Serve as the medical expert for assigned assets studies
  • Contribute to regulatory interactions and strategy, such as IND/CTA/NDA submissions and briefing packages
  • Collaborate with Clinical Operations for site selection, patient recruitment, and 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

Required qualifications

  • 2+ years of industry experience in clinical development
  • Hands-on experience designing and executing clinical trials
  • Experience with regulatory 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

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

Benefits

  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • a year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.

Medical Director, Clinical Development at Kailera | JobZoey