Blackfield Associates are supporting a leading Consumer Goods manufacturing organisaiton, who are seeking a strategic and hands-on Senior Manager, Global Clinical Affairs to lead medical device, OTC, and cosmetics safety and efficacy studies, including claims substantiation. This role is pivotal in designing and managing robust in vitro and clinical programs that meet regulatory requirements and drive product innovation.
What You’ll Do
* Partner with Product Development to create innovative, scientifically sound study strategies.
* Design and oversee safety and claims substantiation studies for diverse product categories.
* Collaborate cross-functionally with Regulatory, Legal, Marketing, and Quality teams to deliver compliant protocols and actionable study results.
* Build and expand internal and external networks with CROs, consultants, auditors, and investigators.
* Manage full study lifecycle: protocol development, budget, monitoring, data interpretation, and reporting.
* Present high-impact study results to inform timely business decisions.
What You Bring
* BS, MS, or PhD in a biological science (e.g., Toxicology, Pharmacology, Biology, Physiology, Biochemistry).
* 8+ years of in vitro and clinical testing experience in medical devices, OTC, or cosmetics.
* Proven ability to lead complex projects across multiple categories and geographies.
* Knowledge of MDR – CER/BER and medical device safety/efficacy testing (preferred).
* Strong communication, problem-solving, and organizational skills.
* Track record of conference presentations and peer-reviewed publications.
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