Senior Medical Director, Clinical Development — Biotech

Regulatory Jobs; Waltham (MA); Presencial; USD 296.000 - 355.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus & equity

Descripción de la vacante

Kailera Therapeutics, Inc. in Waltham, MA is seeking a Senior Medical Director, Clinical Development to design and lead clinical development programs for our obesity-focused pipeline. This role requires biotech experience, strong leadership, and the ability to drive cross-functional collaboration.

The position is on-site 3-4 days per week, with a competitive salary and comprehensive benefits. You will supervise medical monitoring, regulatory strategy, and scientific communications while

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 for protocols and regulatory docs.
• Engages with KOLs, investigators, and cross-functional teams.
• Independent, self-starter with ability to manage multiple studies.
• Advanced PowerPoint; working knowledge of Excel and clinical systems/tools.
• Ability to meet tight deadlines in a fast-paced environment.
• Exceptional attention to detail.

Responsabilidades

• Medical monitoring, reporting and safety activities.
• Provide strategic medical leadership in study design and execution.
• Serve as medical contact for clinical/medical issues.
• Interpret and present product research results.
• Act as medical expert for assets studies.
• Contribute to regulatory interactions and IND/CTA submissions.
• Collaborate with Clinical Operations on site selection and recruitment.
• Oversee data interpretation and clinical study reports.
• Collaborate with Regulatory, Safety, CMC, Medical Affairs, Translational Science.
• Drive partnerships with external collaborators and KOLs.
• Support publications, conferences and external communications.
• Participate in safety review meetings and adverse event input.

Conocimientos

Clinical development

GCP knowledge

Regulatory understanding

KOL engagement

Cross-functional collaboration

Independent/self-starter

PowerPoint

Excel

Multitasking

Attention to detail

Educación

MD or equivalent

Herramientas

Excel

Clinical systems/tools

PowerPoint

Descripción del empleo

Kailera Therapeutics, Inc. in Waltham, MA is seeking a Senior Medical Director, Clinical Development to design and lead clinical development programs for our obesity-focused pipeline. This role requires biotech experience, strong leadership, and the ability to drive cross-functional collaboration.

The position is on-site 3-4 days per week, with a competitive salary and comprehensive benefits. You will supervise medical monitoring, regulatory strategy, and scientific communications while