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.