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Kailera Therapeutics · 2 months ago

Medical Director, Clinical Development

Waltham, Massachusetts

Full-time

Onsite

Lead/Staff, Director/Executive

$205K/yr - $250K/yr

2+ years exp

Kailera is committed to developing therapies that empower individuals to transform their health. They are seeking an experienced Medical Director, Clinical Development to design and execute clinical development programs for innovative therapeutics, requiring strong clinical insight and a deep understanding of drug development.

BiotechnologyPharmaceuticalTherapeutics

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, including IND/CTA 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

Qualification

Clinical development experienceIND submissionsGCP knowledgeClinical trial designRegulatory requirementsSafety monitoringWritten communicationEngagement with KOLsVerbal communicationCross-functional collaborationSelf-starter attitude