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
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Design and oversee next-phase clinical studies, including protocol development, endpoint selection, site selection, and patient enrollment strategy
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Lead clinical data assessment activities, including review of safety and efficacy data, adverse event monitoring, and interim analyses
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Serve as the primary liaison with the FDA, managing pre-IND meetings, IND submissions, and ongoing regulatory correspondence
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Build and maintain a clinical development plan aligned with FDA approval pathway requirements
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Collaborate with research teams, clinical investigators, and CROs to ensure protocol compliance and data integrity
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Oversee preparation and review of clinical study reports, INDs, NDAs/BLAs, and other regulatory submissions
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Identify and manage external CRO and vendor relationships to support trial execution
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Contribute to fundraising and partnering narratives by translating clinical progress into investor- and partner-facing materials
QUALIFICATIONS
Required
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Degree in a life sciences or clinical discipline preferred
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8+ years of clinical development experience in pharmaceutical, biotech, or clinical research settings
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Demonstrated expertise in clinical trial design, protocol development, and statistical endpoint selection
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Hands-on experience managing clinical data assessment, including safety reviews, efficacy analyses, and data integrity oversight
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Direct experience with FDA regulatory submissions and/or communications (IND, NDA, BLA, or equivalent)
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Strong working knowledge of GCP, ICH guidelines, and applicable federal regulations
Preferred
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Prior pharmaceutical or biotech industry experience strongly preferred over pure academic background
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Experience advancing a compound through multiple phases of clinical trials (Phase I through Phase II/III)
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Familiarity with small company or startup environments; ability to operate effectively without large infrastructure
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Established relationships with academic medical centers and clinical investigators
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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.
Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.
California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com.
Benefits Information:
Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.
We look forward to working with you!
Beacon Hill. Employing the Future™
