Company
Healthcare
Director,ClinicalScience
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Clinical Science. Skills: Clinical evidence strategy, Clinical study design, Regulatory submissions, Clinical Science Organization. Own clinical evidence strategy. Translate product concepts into indications”
Industry & Context.
What They're Looking For.
Must Have
Advanced degree in life sciences, medicine, public health, epidemiology, biostatistics, or 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, Deep expertise in clinical study design, Deep expertise in endpoint development, Deep expertise in clinical validation, Deep expertise in statistical analysis planning, Deep expertise in evidence generation strategy, Experience supporting FDA, CE Mark, or other regulatory submissions, Experience authoring and reviewing key clinical and regulatory deliverables, Understanding of medical device and SaMD regulatory requirements, standards, and guidance, Proven ability to influence cross-functional stakeholders, Proven ability to drive decisions across Product, Data Science, Engineering, Regulatory, Quality, and Executive Leadership, Excellent written communication skills, Excellent verbal communication skills
Nice to Have
Experience with Software as a Medical Device (SaMD), Experience with digital health technologies, Preferred experience with wearable technologies, Preferred experience with digital biomarkers, Preferred experience with cardiovascular health, Preferred experience with women’s health, Preferred experience with sleep, Preferred experience with metabolic health, Preferred experience with remote patient monitoring, Familiarity with machine learning-enabled medical devices, Familiarity with algorithm validation, Familiarity with software development lifecycles, Experience interacting with FDA, Experience interacting with Notified Bodies, Experience interacting with auditors, Experience interacting with other regulatory agencies, Experience working in sponsor environments, Experience working in CRO environments, Working knowledge of R, Working knowledge of SAS, Working knowledge of Python, Working knowledge of SQL, Working knowledge of CDISC, Working knowledge of SDTM, Working knowledge of ADaM, Experience building a clinical science function, Experience scaling a clinical science function
What You'll Do.
Own clinical evidence strategy
Translate product concepts into indications
Translate product concepts into claims
Translate product concepts into endpoints
Translate product concepts into evidence strategies
Define clinical validation strategies
Lead design of feasibility studies
Lead design of validation studies
Lead design of post-market studies
Lead oversight of feasibility studies
Lead oversight of validation studies
Lead oversight of post-market studies
Lead clinical strategy for FDA
Lead clinical strategy for CE Mark
Lead clinical strategy for other regulatory pathways
Lead evidence development for FDA
Lead evidence development for CE Mark
Lead evidence development for other regulatory pathways
Participate in regulatory interactions
Review clinical content for submissions
Develop key clinical deliverables
Review key clinical deliverables
Approve key clinical deliverables
Serve as clinical subject matter expert
Serve as scientific subject matter expert
Partner closely with Product
Partner closely with Data Science
Partner closely with Engineering
Partner closely with Regulatory
Partner closely with Quality
Partner closely with Legal
Partner closely with Commercial teams
Build Clinical Science organization
Lead Clinical Science organization
Hire Clinical Science staff
Mentor Clinical Science staff
Plan Clinical Science workforce
Establish scalable processes
Establish scalable standards
Establish scalable operating models
Communicate scientific concepts
Communicate clinical concepts
Communicate regulatory concepts
Communicate to technical stakeholders
Communicate to non-technical stakeholders
Communicate to executive leadership
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Product teams; Data Science teams; Engineering teams; Regulatory teams; Quality teams; Legal teams; Commercial teams; Internal stakeholders; Regulators; Investigators; Advisors; External partners
Communication Scope
Written communication; Verbal communication; Translate complex concepts
Full Job Description
## 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 healt
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