Medical Director, Clinical Development

We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.

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, Medical Affairs, 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

Requirements

3+ years of industry experience in clinical development, preferably in a biotech or small pharma environment; 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; Ability to 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; MD or equivalent is required

Nice to have

Experience in cardiometabolic therapeutic area is advantageous; Proven track record of contributing to IND submissions and global regulatory filings is a strong plus

Benefits

Comprehensive health coverage; Flexible time off; Paid holidays; Year-end shutdown; Monthly wellness stipend; Generous 401(k) match; Tuition reimbursement; Commuter benefits; Disability and life insurance; Annual bonus opportunities; Equity grants