Director, Clinical Science

RESPONSIBILITIES

• Own the clinical evidence strategy across WHOOP’s portfolio of regulated and unregulated health features, including feasibility, validation, regulatory submission, launch, and post-market evidence generation.
• Translate product concepts and algorithms into clinically meaningful indications, claims, endpoints, and evidence strategies.
• Define clinical validation strategies, including study design, comparator selection, endpoint development, sample size justification, statistical analysis planning, success criteria, and evidence requirements.
• Lead the design and oversight of feasibility, validation, and post-market studies supporting product development and regulatory objectives.
• Lead clinical strategy and evidence development for FDA, CE Mark, and other regulatory pathways, including participation in regulatory interactions and review of clinical content for submissions.
• Develop, review, and approve key clinical deliverables, including protocols, CRFs, SAPs, CSRs, CERs, and regulatory submission content.
• Serve as the clinical and scientific subject matter expert for internal stakeholders, regulators, investigators, advisors, and external partners.
• Partner closely with Product, Data Science, Engineering, Regulatory, Quality, Legal, and Commercial teams to ensure clinical evidence informs product, regulatory, and business decisions.
• Build and lead a high-performing Clinical Science organization, including hiring, mentoring, workforce planning, and establishing scalable processes, standards, and operating models.
• Communicate complex scientific, clinical, and regulatory concepts to technical and non-technical stakeholders, including executive leadership.

QUALIFICATIONS

• Advanced degree (PhD, MD, PharmD, DrPH, MPH/MS with significant relevant experience, or equivalent) in life sciences, medicine, public health, epidemiology, biostatistics, or a related field.
• 10+ years of experience in clinical science, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
• 5+ years of experience leading and developing clinical science or clinical research teams.
• Demonstrated experience leading clinical evidence generation for regulated products, ideally including Software as a Medical Device (SaMD) or digital health technologies.
• Deep expertise in clinical study design, endpoint development, clinical validation, statistical analysis planning, and evidence generation strategy.
• Experience supporting FDA, CE Mark, or other regulatory submissions, including development of clinical evidence and participation in regulatory interactions.
• Experience authoring and reviewing key clinical and regulatory deliverables, including protocols, SAPs, CSRs, CERs, and submission documentation.
• Strong understanding of medical device and SaMD regulatory requirements, standards, and guidance.
• Proven ability to influence cross-functional stakeholders and drive decisions across Product, Data Science, Engineering, Regulatory, Quality, and Executive Leadership.
• Excellent written and verbal communication skills, with the ability to translate complex scientific and regulatory concepts for diverse audiences.
• Preferred experience with wearable technologies, digital biomarkers, cardiovascular health, women’s health, sleep, metabolic health, or remote patient monitoring.
• Familiarity with machine learning-enabled medical devices, algorithm validation, and software development lifecycles preferred.
• Experience interacting with FDA, Notified Bodies, auditors, or other regulatory agencies preferred.
• Experience working in both sponsor and CRO environments preferred.
• Working knowledge of statistical and data analysis tools such as R, SAS, Python, SQL, CDISC, SDTM, or ADaM preferred.
• Experience building or scaling a clinical science function within a growing organization preferred.