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.