Principal Clinical Scientist

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Clinical Scientist based in the United States.** The Principal Clinical Scientist will lead clinical trial strategies supporting diagnostic products across the US and EU markets. This is a high-impact scientific role focused on generating robust clinical evidence for regulatory submissions and product commercialization. You will shape study designs, protocols, evidence plans, and clinical claims across multiple diagnostic technologies. The role requires close collaboration with Regulatory, R&D, Medical Affairs, Quality, Commercial teams, clinical sites, and external scientific experts. You will serve as a trusted scientific liaison with regulatory authorities and key opinion leaders while addressing complex clinical and scientific challenges. The position also offers opportunities to mentor junior scientists and influence clinical strategy within a global diagnostics environment. With a fully remote setup and limited international travel, this role combines scientific leadership, cross-functional influence, and meaningful patient impact. ### Accountabilities - Design and execute clinical study strategies and evidence-generation plans supporting global regulatory submissions, including FDA 510(k)/PMA and CE IVDR pathways. - Develop clinical protocols, claims, and evidence strategies in collaboration with internal stakeholders, external clinical sites, regulatory bodies, and key opinion leaders. - Serve as a scientific and clinical liaison, communicating clinical evidence and study strategies to regulatory and external scientific audiences. - Partner closely with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to ensure clinical programs align with product development, regulatory, and market-access objectives. - Author, review, and provide scientific oversight for clinical and regulatory documentation, including study reports, technical files, and scientific publications. - Critically evaluate clinical and scientific data and provide expert interpretation to support evidence-based decisions and regulatory strategies. - Identify, investigate, and resolve complex issues related to clinical trial execution, study methodology, and scientific interpretation. - Maintain strong relationships with internal and external collaborators and contribute clinical expertise to multidisciplinary initiatives. - Mentor and support junior scientists, promoting scientific rigor, knowledge sharing, and professional development. - Maintain current knowledge of evolving regulatory requirements, clinical guidelines, clinical research methodologies, and diagnostic technologies. ## Requirements - Bachelor’s degree in Life Sciences, Healthcare, or a related field with **9+ years of relevant clinical research experience**, including significant US and/or EU trial experience; alternatively, a Master’s degree with **12+ years** of experience or a Doctoral degree with **4+ years** of experience. - Deep understanding of clinical study design and methodology within the diagnostics, medical device, or pharmaceutical industries, particularly for products targeting US and EU markets. - Demonstrated experience developing and overseeing clinical strategies, protocols, evidence plans, and clinical documentation. - Strong ability to critically review, interpret, and communicate scientific and clinical trial data. - Proven ability to identify and resolve complex issues associated with clinical trial conduct and scientific interpretation. - Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional and external stakeholders. - Strong interpersonal skills and the ability to build productive relationships with clinical sites, regulatory stakeholders, scientific experts, and internal teams. - Experience with in vitro diagnostic (IVD) technologies, particularly within **Hematology and Urinalysis**, is highly preferred. - An advanced degree in Science, Healthcare, Regulatory Affairs, or Clinical Affairs is advantageous. - Professional clinical research certification, such as SoCRA or ACRP, is a plus. - Ability to work effectively in a remote environment while maintaining strong ownership, organization, and cross-functional collaboration. - Willingness to travel up to **10%**, including overnight travel within the US and/or EU. - Valid driver’s license with an acceptable driving record required. ## Benefits - Annual salary range of approximately **$130,000–$150,000**, subject to experience, qualifications, location, and other applicable factors. - Eligibility for bonus and/or incentive compensation. - Fully remote work arrangement from home. - Medical, dental, and vision insurance for eligible employees. - Paid time off. - 401(k) retirement plan. - Comprehensive benefits designed to support employee well-being and life beyond work. - Opportunity to work on clinical strategies that support innovative diagnostic technologies and regulatory submissions. - Collaborative, cross-functional environment with opportunities for scientific leadership and mentoring.