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At Thorne , we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne , you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.The Director Clinical Affairs is responsible for leading the strategic design, execution, and
oversight of clinical research and consumer study programs for Thorne ’s greater Research and Development (R&D) department. The clinical and consumer study program will be designed to enable differentiated claims on Thorne ’s core/existing and new products being introduced into the portfolio.
This role combines clinical trial operations management with regulatory and business alignment, ensuring that studies are executed with excellence, compliant with global standards, and generate evidence that support finished product claims for commercial products. This role will collaborate cross-functionally with Medical & Scientific Affairs, Product Development, Marketing, Legal, and Regulatory teams to ensure clinical evidence meets internal standards and external regulatory and GCP requirements.
The ideal candidate has deep expertise in operational excellence of clinical trial management, vendor/CRO management, scientific communications, evidence-based study design and execution for dietary supplement, nutritional and/or functional food products. The Director Clinical Affairs will lead the 3C Subcommittee which governs all R&D led Clinical and Consumer Perception studies end-to-end from design to completion.
RESPONSIBILITIES
Clinical Strategy – Define and implement the clinical research roadmap aligned with product innovation and core business objectives; identify opportunities for differentiated science and evidence-based claims.
Claims Development & Validation – Partner with Medical & Scientific Affairs, Product Development, Marketing, Legal, and Regulatory to design studies that substantiate new finished product claims and ensure claims are scientifically credible, compliant, and marketable. 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.
Regulatory & Compliance – Ensure compliance with GCP, ICH, FDA, FTC, etc.; oversee preparation and review of study protocols, consent forms, and final reports.
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 – Build and mentor a high-performing clinical affairs and operations team; foster a culture of operational excellence, compliance, and innovation.
Operational Excellence – Develop KPIs and performance dashboards to track study progress; continuously improve clinical workflows, efficiency, and compliance.
Collaborate with Thorne ’s R&D team on identifying and managing opportunities to publish.
Is proficient in appropriate FTC, cGLP, cGCP, cGMP, and FDA compliance standards.
Consistently stays current on the scientific, technical, and market trends relevant to all of Thorne ’s products, initiatives, and divisions.
Provide support for new product development, product research, and market strategy.
Builds and leads a highly performing Clinical Affairs team, securing the best talent, developing and strengthening staff and future leaders, and providing ongoing coaching and feedback.
Fosters a culture of continuous learning and provides growth opportunities through knowledge to teammates.
Conducts formal and informal performance assessments of staff, including performance versus expectations and goals, behaviors and leadership potential, and seeks the same for self.
Functions as a contributor to consumer and professional content/media as appropriate.
WHAT YOU NEED
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 in designing and managing human clinical trials and consumer claims studies in a leadership role.
Strong knowledge of clinical trial methodology, GCP, ICH, FDA, 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.