Strategic Medical Director, Biotech Clinical Development

Kailera Therapeutics; Waltham (MA); On-site; USD 296,000 - 355,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Monthly wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics in Waltham, MA is seeking a Senior Medical Director, Clinical Development to lead design and execution of clinical development programs. The role requires strong clinical insight, cross-functional collaboration, and hands-on trial leadership in a fast-paced biotech setting.

The successful candidate will work onsite 3-4 days per week, partner with Regulatory, Safety, and Medical Affairs teams, and contribute to IND/CTA submissions and publications.

Qualifications

• 4+ years of industry experience in clinical development.
• Hands-on experience designing and executing clinical trials.
• Understanding of GCP, trial design, regulatory requirements, and safety monitoring.
• Excellent written and verbal communication, including protocol and regulatory writing.
• Engagement with KOLs, investigators, and cross-functional teams.
• Independent self-starter with initiative.
• Advanced PowerPoint skills; working knowledge of Excel and clinical systems/tools.
• Ability to manage multiple studies and deadlines in a fast-paced environment; highly detail oriented.

Responsibilities

• Medical monitoring/reporting and safety activities.
• Provide strategic medical leadership in design, planning, and execution of clinical development strategies.
• Serve as the medical contact for clinical/medical issues.
• Interpret, report, and prepare results of product research with senior clinical personnel.
• Act as medical expert for assigned assets studies.
• Contribute to regulatory interactions and IND/CTA submissions.
• Collaborate with Clinical Operations for site selection and patient recruitment strategies.
• Oversee data interpretation, analysis, and study reports.
• Work with Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams.
• Drive partnerships with external collaborators, KOLs, CROs, and investigators.
• Support publications, conferences, and other external communications.
• Participate in safety review meetings and provide input on adverse events.

Job description

Kailera Therapeutics in Waltham, MA is seeking a Senior Medical Director, Clinical Development to lead design and execution of clinical development programs. The role requires strong clinical insight, cross-functional collaboration, and hands-on trial leadership in a fast-paced biotech setting.

The successful candidate will work onsite 3-4 days per week, partner with Regulatory, Safety, and Medical Affairs teams, and contribute to IND/CTA submissions and publications.