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Lead the development of clinical strategies and evidence for health features, manage a team of Clinical Scientists, and ensure regulatory compliance.
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.
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.
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.
RESPONSIBILITIES:
- Lead clinical strategy across multiple initiatives, from feature ideation to post-market activities.
- Serve as a scientific and clinical subject matter expert in internal discussions and external engagements (e.g., FDA, Notified Bodies).
- Shape evidence generation plans to support regulatory submissions and business priorities.
- Oversee clinical data generation, ensuring adherence to CDISC and regulatory standards.
- Develop and review documentation including study protocols, CRFs, SAPs, and regulatory submissions (e.g., CERs, CSRs, 510(k) packages).
- Maintain and grow collaborative relationships with regulatory agencies (e.g., FDA, EMA), including pre-submission meetings and ongoing communications.
- Partner with Regulatory and Quality teams to ensure compliance with ICH-GCP, ISO 14155, and FDA regulations.
- Manage and mentor Clinical Scientists, fostering high-quality scientific execution and career development.
- Conduct technical reviews and quality control of scientific documentation and statistical deliverables.
- Support hiring and onboarding efforts to build a well-rounded clinical function.
- Work closely with product, data science, engineering, and legal teams to ensure clinical and scientific input throughout the product lifecycle.
- Partner with data teams to analyze and interpret clinical and real-world datasets.
QUALIFICATIONS:
- Advanced degree (Ph.D., MD, or PharmD) in life sciences, public health, or a related field.
- 7+ years of experience in clinical research or clinical science, including at least 2 years of direct people management or team leadership.
- Demonstrated experience leading full-cycle clinical trials or regulated studies in digital health, medical devices (esp. SaMD), or pharmaceuticals.
- Led or contributed to SaMD regulatory submissions (e.g., 510(k), De Novo, CE Mark)
- Strong knowledge of clinical data standards and tools - CDISC (SDTM/ADaM), R, SAS, and/or Python.
- Deep understanding of FDA and international regulatory pathways and documentation requirements.
- Proven ability to build cross-functional relationships and communicate clearly across technical and non-technical teams.
- Experience mentoring junior team members and conducting quality checks on clinical and regulatory deliverables.
- Nice to have: Prior experience working at or closely with a regulatory agency (e.g., FDA), or a strong history of successful regulatory interactions.
- Nice to have: Background in both CRO and sponsor-side clinical roles.
- Nice to have: Familiarity with software validation processes and SaMD evidence generation.
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.
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.
WHOOP is an Equal Opportunity Employer and participates in E-verify 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.
Top Skills
Cdisc
Python
R
SAS
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Manage regulatory affairs for medical devices, lead submissions, ensure compliance with quality systems, and mentor teams at WHOOP.
Top Skills:
21 Cfr 820De Novo ClassificationFda 510(K)Iso 13485:2016
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