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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.
Job Responsibility:
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
Requirements:
2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
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
MD or equivalent is required
Nice to have:
Experience across multiple therapeutic areas, including obesity, is advantageous
Proven track record of contributing to BLA/NDA submissions is a strong plus
What we offer:
Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
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