Strategic Medical Director, Biotech Clinical Development

Kailera Therapeutics; Waltham (MA); Presencial; USD 296.000 - 355.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Descripción del empleo

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.