<div>WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.</div><div><br /></div><div>As the Lead Clinical Science Manager, you will drive the end-to-end development of clinical strategy and scientific evidence across a portfolio of innovative health features spanning both regulated and unregulated domains. This role combines subject matter expertise, regulatory-savvy strategy, and hands-on leadership in clinical trial design, data analysis, and cross-functional alignment.</div><div><br /></div><div>You will manage and mentor a growing team of Clinical Scientists, lead high-impact clinical studies, and help WHOOP generate the evidence required for product development, regulatory submissions, and long-term member trust. This role is ideal for someone with strong clinical acumen, technical fluency, and deep experience in digital health, medical device development, or pharmaceutical trials.</div><h3>RESPONSIBILITIES:</h3><ul><li>Lead clinical strategy across multiple initiatives, from feature ideation to post-market activities.</li><li>Serve as a scientific and clinical subject matter expert in internal discussions and external engagements (e.g., FDA, Notified Bodies).</li><li>Shape evidence generation plans to support regulatory submissions and business priorities.</li><li>Oversee clinical data generation, ensuring adherence to CDISC and regulatory standards.</li><li>Develop and review documentation including study protocols, CRFs, SAPs, and regulatory submissions (e.g., CERs, CSRs, 510(k) packages).</li><li>Maintain and grow collaborative relationships with regulatory agencies (e.g., FDA, EMA), including pre-submission meetings and ongoing communications.</li><li>Partner with Regulatory and Quality teams to ensure compliance with ICH-GCP, ISO 14155, and FDA regulations.</li><li>Manage and mentor Clinical Scientists, fostering high-quality scientific execution and career development.</li><li>Conduct technical reviews and quality control of scientific documentation and statistical deliverables.</li><li>Support hiring and onboarding efforts to build a well-rounded clinical function.</li><li>Work closely with product, data science, engineering, and legal teams to ensure clinical and scientific input throughout the product lifecycle.</li><li>Partner with data teams to analyze and interpret clinical and real-world datasets.</li></ul><h3>QUALIFICATIONS:</h3><ul><li>Advanced degree (Ph.D., MD, or PharmD) in life sciences, public health, or a related field.</li><li>7+ years of experience in clinical research or clinical science, including at least 2 years of direct people management or team leadership.</li><li>Demonstrated experience leading full-cycle clinical trials or regulated studies in digital health, medical devices (esp. SaMD), or pharmaceuticals.</li><li>Led or contributed to SaMD regulatory submissions (e.g., 510(k), De Novo, CE Mark)</li><li>Strong knowledge of clinical data standards and tools - CDISC (SDTM/ADaM), R, SAS, and/or Python.</li><li>Deep understanding of FDA and international regulatory pathways and documentation requirements.</li><li>Proven ability to build cross-functional relationships and communicate clearly across technical and non-technical teams.</li><li>Experience mentoring junior team members and conducting quality checks on clinical and regulatory deliverables.</li><li>Nice to have: Prior experience working at or closely with a regulatory agency (e.g., FDA), or a strong history of successful regulatory interactions.</li><li>Nice to have: Background in both CRO and sponsor-side clinical roles.</li><li>Nice to have: Familiarity with software validation processes and SaMD evidence generation.</li></ul><div><i><b>This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.</b><b> </b></i></div><div><br /></div><div><i>Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.</i></div><div><br /></div><div><i>WHOOP is an Equal Opportunity Employer and participates in </i><a href="https://www.e-verify.gov/"><i>E-verify</i></a><i> to determine employment eligibility.  It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.</i></div>