Director of Clinical Development and Regulatory Affairs

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We are seeking an experienced Director of Clinical Development & Regulatory Affairs to lead next-phase study design and execution strategy in preparation for FDA submission. This individual will serve as a key scientific and operational leader, working closely with research partners, CROs, and internal stakeholders to design rigorous studies, manage clinical data, and build a compelling, submission-ready regulatory package. This role offers the potential to grow into a senior executive position as the organization scales. This is a St. Louis-based role, with a broader team operating remotely; comfort with distributed collaboration is essential.

KEY RESPONSIBILITIES

• Design and oversee next-phase clinical studies, including protocol development, endpoint selection, site selection, and patient enrollment strategy
• Lead clinical data assessment activities, including review of safety and efficacy data, adverse event monitoring, and interim analyses
• Serve as the primary liaison with the FDA, managing pre-IND meetings, IND submissions, and ongoing regulatory correspondence
• Build and maintain a clinical development plan aligned with FDA approval pathway requirements
• Collaborate with research teams, clinical investigators, and CROs to ensure protocol compliance and data integrity
• Oversee preparation and review of clinical study reports, INDs, NDAs/BLAs, and other regulatory submissions
• Identify and manage external CRO and vendor relationships to support trial execution
• Contribute to fundraising and partnering narratives by translating clinical progress into investor- and partner-facing materials

QUALIFICATIONS

Required

• Degree in a life sciences or clinical discipline preferred
• 8+ years of clinical development experience in pharmaceutical, biotech, or clinical research settings
• Demonstrated expertise in clinical trial design, protocol development, and statistical endpoint selection
• Hands-on experience managing clinical data assessment, including safety reviews, efficacy analyses, and data integrity oversight
• Direct experience with FDA regulatory submissions and/or communications (IND, NDA, BLA, or equivalent)
• Strong working knowledge of GCP, ICH guidelines, and applicable federal regulations

Preferred

• Prior pharmaceutical or biotech industry experience strongly preferred over pure academic background
• Experience advancing a compound through multiple phases of clinical trials (Phase I through Phase II/III)
• Familiarity with small company or startup environments; ability to operate effectively without large infrastructure
• Established relationships with academic medical centers and clinical investigators
• Experience with academic-industry research partnerships

COMPENSATION & CULTURE
Offers a competitive compensation package commensurate with experience, including base salary, performance bonus, and equity participation. The team values professionals who thrive in lean, mission-driven environments and want ownership in outcomes.

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