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Thorne is seeking a Director of Clinical Affairs to lead the strategic design, execution, and oversight of clinical research and consumer study programs for the R&D department. This role is responsible for building and managing a high-performing clinical affairs team while ensuring all clinical trials and consumer studies generate evidence that supports product claims for Thorne's dietary supplements, nutritional products, and functional foods.
Key responsibilities include:
**Clinical Strategy & Claims Development**: Define and implement the clinical research roadmap aligned with product innovation and business objectives. Partner cross-functionally with Medical & Scientific Affairs, Product Development, Marketing, Legal, and Regulatory teams to design studies that substantiate new product claims. Translate clinical findings into product claims, business strategies, and consumer messaging.
**Clinical Operations Leadership**: Oversee end-to-end planning and execution of human clinical trials, including protocol development, site and vendor selection, project timelines, budgeting, and risk management. Lead the 3C Subcommittee governing all R&D-led clinical and consumer perception studies from design to completion.
**Regulatory & Compliance**: Ensure compliance with GCP, ICH, FDA, FTC, and other applicable standards. Oversee preparation and review of study protocols, informed consent forms, and final reports. Maintain proficiency in FTC, cGLP, cGCP, cGMP, and FDA compliance standards.
**Data Integrity & Reporting**: Direct data collection, analysis, and reporting processes. Partner with biostatistics and medical writing teams to ensure accurate publications, regulatory submissions, and substantiated claims.
**Vendor & Stakeholder Management**: Manage relationships with CROs, investigators, and academic partners to ensure high-quality performance and scientific integrity.
**Team Leadership & Culture**: Build and mentor a high-performing clinical affairs team. Foster a culture of operational excellence, compliance, and innovation. Conduct formal and informal performance assessments and provide ongoing coaching and feedback.
**Operational Excellence**: Develop KPIs and performance dashboards to track study progress. Continuously improve clinical workflows, efficiency, and compliance. Stay current on scientific, technical, and market trends relevant to Thorne's products and divisions.
**Additional Responsibilities**: Support new product development and market strategy. Collaborate on identifying and managing publication opportunities. Function as a contributor to consumer and professional content/media as appropriate.
**Requirements:**
- Bachelor's degree in Life Sciences, Clinical Research, or related field (advanced degree preferred: MSc, PhD, MD)
- 7–10+ years of experience in clinical research and clinical operations roles in consumer-packaged goods, dietary supplements, nutritional and/or functional foods
- Proven experience designing and managing human clinical trials and consumer claims studies in a leadership role
- Strong knowledge of clinical trial methodology, GCP, ICH, FDA, and FTC regulations and standards
- Expertise in project management, budgeting, vendor oversight, and risk management
- Solid understanding of biostatistics and data integrity principles
- Ability to communicate complex scientific data to technical, regulatory, and business stakeholders
- Understanding of consumer-packaged goods (natural supplements and/or other) and/or pharmaceutical clinical practices
- Experience writing educational content for various audiences including consumers, healthcare professionals, and others
