Senior Medical Director, Clinical Development Lead

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

Ventajas ofrecidas por este puesto de trabajo

Comprehensive health coverage

Flexible time off

Paid holidays

Year-end shutdown

Monthly wellness stipend

Generous 401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus opportunities

Equity grants

Descripción de la vacante

Kailera Therapeutics, Inc. is seeking a Senior Medical Director, Clinical Development to lead design and execution of clinical development programs for a growing pipeline in obesity and related conditions.

The role requires deep clinical insight, biotech drug development experience, and the ability to drive cross-functional collaboration in a fast-paced, hub-based environment in Waltham, MA. Onsite 3-4 days per week with strong leadership responsibilities.

Formación

• MD or equivalent required.
• 4+ years of industry experience in clinical development, preferably in biotech or small pharma.
• Hands-on experience designing and executing clinical trials.
• 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.
• Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools.
• Ability to manage multiple studies and deadlines in a fast-paced environment.
• Must be exceptionally detail oriented.

Responsabilidades

• Responsible for medical monitoring/reporting and safety activities
• Provide strategic 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
• Serves as the medical expert for assigned assets studies
• Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
• Collaborate with Clinical Operations to ensure site selection, patient recruitment strategies, and high-quality trial execution
• Oversee and support data interpretation, analysis, and clinical study reports
• Work with Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams
• Drive partnerships with external collaborators, KOLs, CROs, and investigators
• Support scientific publications, conference presentations, and external communications
• Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting

Conocimientos

Clinical trial design

GCP & regulatory requirements

Scientific writing

Cross-functional collaboration

Data interpretation

Publications/presentations

Project management

Attention to detail

Independent work

PowerPoint / Excel skills

Educación

MD or equivalent

Descripción del empleo

Kailera Therapeutics, Inc. is seeking a Senior Medical Director, Clinical Development to lead design and execution of clinical development programs for a growing pipeline in obesity and related conditions.

The role requires deep clinical insight, biotech drug development experience, and the ability to drive cross-functional collaboration in a fast-paced, hub-based environment in Waltham, MA. Onsite 3-4 days per week with strong leadership responsibilities.