Lead Clinical Research Scientist

RESPONSIBILITIES:

• Lead clinical strategy across multiple initiatives, from feature ideation to post-market activities.
• Serve as a scientific and clinical subject matter expert in internal discussions and external engagements (e.g., FDA, Notified Bodies).
• Shape evidence generation plans to support regulatory submissions and business priorities.
• Oversee clinical data generation, ensuring adherence to CDISC and regulatory standards.
• Develop and review documentation including study protocols, CRFs, SAPs, and regulatory submissions (e.g., CERs, CSRs, 510(k) packages).
• Maintain and grow collaborative relationships with regulatory agencies (e.g., FDA, EMA), including pre-submission meetings and ongoing communications.
• Partner with Regulatory and Quality teams to ensure compliance with ICH-GCP, ISO 14155, and FDA regulations.
• Manage and mentor Clinical Scientists, fostering high-quality scientific execution and career development.
• Conduct technical reviews and quality control of scientific documentation and statistical deliverables.
• Support hiring and onboarding efforts to build a well-rounded clinical function.
• Work closely with product, data science, engineering, and legal teams to ensure clinical and scientific input throughout the product lifecycle.
• Partner with data teams to analyze and interpret clinical and real-world datasets.

QUALIFICATIONS:

• Advanced degree (Ph.D., MD, or PharmD) in life sciences, public health, or a related field.
• 7+ years of experience in clinical research or clinical science, including at least 2 years of direct people management or team leadership.
• Demonstrated experience leading full-cycle clinical trials or regulated studies in digital health, medical devices (esp. SaMD), or pharmaceuticals.
• Led or contributed to SaMD regulatory submissions (e.g., 510(k), De Novo, CE Mark)
• Strong knowledge of clinical data standards and tools - CDISC (SDTM/ADaM), R, SAS, and/or Python.
• Deep understanding of FDA and international regulatory pathways and documentation requirements.
• Proven ability to build cross-functional relationships and communicate clearly across technical and non-technical teams.
• Experience mentoring junior team members and conducting quality checks on clinical and regulatory deliverables.
• Nice to have: Prior experience working at or closely with a regulatory agency (e.g., FDA), or a strong history of successful regulatory interactions.
• Nice to have: Background in both CRO and sponsor-side clinical roles.
• Nice to have: Familiarity with software validation processes and SaMD evidence generation.