Kailera

Senior Medical Director, Clinical Development

Waltham, Massachusetts. 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 strategic medical leadership and act as the medical contact for clinical issues.

What you will do

  • Responsible for medical monitoring/reporting and safety activities
  • Provide strategic 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
  • Serves as the medical expert for assigned assets studies
  • Contribute to regulatory interactions and strategy, including IND/CTA 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, Medical Affairs, and Translational Science teams
  • Drive partnerships with external collaborators, KOLs, CROs, and investigators

Required qualifications

  • 4+ years of industry experience in clinical development
  • Hands-on experience designing and executing clinical trials
  • Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
  • Excellent written and verbal communication skills
  • Ability to engage with KOLs, investigators, and cross-functional teams
  • Can work independently
  • Advanced PowerPoint skills
  • Working knowledge of Excel and other commonly used clinical systems/tools
  • Ability to manage multiple studies and deadlines in a fast-paced environment
  • Must be exceptionally detail oriented
  • MD or equivalent

Nice to have

  • Experience in cardiometabolic therapeutic area
  • Proven track record of contributing to IND submissions and global regulatory filings

Benefits

  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • 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.

Senior Medical Director, Clinical Development at Kailera | JobZoey