Thorne

Purity-focused nutritional supplements with scientific rigor

Director Clinical Affairs

Clinical Research OperationsUpdated on Nov 13

Full-timeSouth Carolina, USA$150k - $170k /yrRemote

About the Job

Requirements

A bachelor's degree in Life Sciences, Clinical Research, or a related field is required.
At least 5 years of experience in clinical research and clinical operations roles in consumer-packaged goods, dietary supplements, nutritional products, or functional foods is required.
Experience designing for DSHEA-compliant claims is required.
Proven experience designing and managing human clinical trials and consumer claims studies in a leadership role is required.
Strong knowledge of clinical trial methodology, GCP, ICH, FDA, and FTC regulations and standards is required.
Expertise in project management, budgeting, vendor oversight, and risk management is required.
A solid understanding of biostatistics and data integrity principles is required.
The ability to communicate complex scientific data to technical, regulatory, and business stakeholders is required.
An understanding of consumer-packaged goods, such as natural supplements, and/or pharmaceutical clinical practices is required.
Experience writing educational content for audiences including consumers and healthcare professionals is required.
Proficiency in appropriate FTC, cGLP, cGCP, cGMP, and FDA compliance standards is required.

Responsibilities

Lead the strategic design, execution, and oversight of clinical research and consumer study programs for the Research and Development department to enable differentiated claims for existing and new products.
Define and implement the clinical research roadmap in alignment with product innovation and core business objectives, identifying opportunities for differentiated science and evidence-based claims.
Partner with Medical and Scientific Affairs, Product Development, Marketing, Legal, and Regulatory teams to design studies substantiating new finished-product claims and ensure claims are scientifically credible, compliant, and marketable.
Translate clinical findings into product claims, business strategies, and consumer messaging.
Oversee end-to-end planning and execution of human clinical trials, including protocol development, site and vendor selection, project timelines, budgeting, and risk management.
Ensure compliance with GCP, ICH, FDA, and FTC requirements, and oversee preparation and review of study protocols, consent forms, and final reports.
Direct data collection, analysis, and reporting, partnering with biostatistics and medical writing teams on accurate publications, regulatory submissions, and substantiated claims.
Manage relationships with CROs, investigators, and academic partners to ensure high-quality performance and scientific integrity.
Build, lead, and mentor a high-performing Clinical Affairs and operations team; secure talent, develop staff and future leaders, and provide coaching and feedback.
Establish KPIs and performance dashboards to track study progress and continuously improve clinical workflows, efficiency, and compliance.
Collaborate with the Research and Development team to identify and manage publication opportunities.
Stay current on scientific, technical, and market trends relevant to the company's products, initiatives, and divisions.
Support new product development, product research, and market strategy.
Foster continuous learning and provide teammates with growth opportunities through knowledge-sharing.
Conduct formal and informal staff performance assessments covering performance against expectations and goals, behaviors, and leadership potential, and seek the same feedback for oneself.
Contribute to consumer and professional content and media as appropriate.

Desired Qualifications

An advanced degree such as an MSc, PhD, or MD is preferred.

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.

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.

Bachelor’s degree in Life Sciences, Clinical Research, or related field (advanced degree preferred: MSc, PhD, MD).
5+ years of experience in clinical research and clinical operations roles in consumer-packaged goods, dietary supplements, nutritional and/or functional foods.
Design for DSHEA friendly claims.
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.
Understanding of consumer-packaged goods (natural supplements and/or other) and/or pharmaceutical clinical practices.
Experience in writing educational content for various audiences including (but not limited to), Consumers, HCP’s, etc.

About the Company

Thorne

Purity-focused nutritional supplements with scientific rigor

Thorne is a health and wellness company that makes nutritional supplements. It focuses on purity and scientific backing, testing its products to ensure quality and efficacy for consumers. Its products work by delivering carefully studied nutrients and other ingredients in supplements that people take to support their health. Thorne differentiates itself from competitors through a long history dating back to 1984, a strong emphasis on quality and scientific integrity, and rigorous quality controls. In 2023 the company was acquired by L Catterton, moved off public markets, and continues to pursue growth by expanding research and development. The overall goal is to provide reliable, high-quality supplements that people can trust to support their health and well-being.

Company size: 501-1,000
Company stage: IPO
Headquarters: New York City, United States
Founded: 1984

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