Company

Healthcare

Director,ClinicalScience

$220–320k ~AI est. Boston, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Healthcare

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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