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.
Requirements
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, Py
Benefits
Health insuranceRemote work options
Additional Information
WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. WHOOP empowers members to improve their health through a deeper understanding of their bodies and daily lives.
As the Director, Clinical Science, you will lead the clinical science function responsible for developing the evidence that supports WHOOP's regulated and unregulated health features, with a particular focus on Software as a Medical Device (SaMD). You will own clinical strategy across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence generation.
This role requires deep expertise in SaMD clinical development, including study design, endpoint development, clinical validation, regulatory strategy, and evidence generation. As both a strategic leader and hands-on expert, you will partner closely with cross-functional teams to ensure clinical evidence supports product, regulatory, and business objectives.
You will build and mentor a high-performing team of Clinical Scientists, strengthen WHOOP's clinical science capabilities, and ensure our evidence generation strategy meets the expectations of regulators, clinicians, members, and the business.
Whoop · Boston, MA