Medical Director, Clinical Development - Remote/Hybrid

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 242,000 - 290,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Tuition reimbursement

Paid holidays

Wellness stipend

Equity grants

Annual bonus

Commuter benefits

Job summary

Kailera Therapeutics, Inc. in Waltham, MA seeks a Medical Director, Clinical Development to design and execute clinical development programs advancing our obesity-focused therapeutics.

Onsite 3-4 days a week, or remote with hub visits, you will lead multi-study strategies and medical decisions. Requirements include an MD or equivalent and 2+ years in biotech clinical development, with regulatory submissions experience and strong cross-functional collaboration.

Qualifications

• 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 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.

Responsibilities

• 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, such as IND/CTA/NDA 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.

Skills

Clinical development

Trial design

Regulatory submissions

GCP knowledge

Communication

KOL engagement

Education

MD or equivalent

Job description

Kailera Therapeutics, Inc. in Waltham, MA seeks a Medical Director, Clinical Development to design and execute clinical development programs advancing our obesity-focused therapeutics.

Onsite 3-4 days a week, or remote with hub visits, you will lead multi-study strategies and medical decisions. Requirements include an MD or equivalent and 2+ years in biotech clinical development, with regulatory submissions experience and strong cross-functional collaboration.