Director, Clinical Science

United States Digital Space LLC; Boston (MA); On-site; USD 220,000 - 245,000; Full time

Job summary

United States Digital Space LLC in Boston, MA seeks a Director of Clinical Science to lead evidence generation for SaMD across the product lifecycle, from feasibility to post-market strategies.

The role combines strategic leadership with hands-on clinical science, building a high-performing team, and partnering with Product, Data Science, Engineering, and Regulatory to support regulatory submissions and product decisions.

Qualifications

• 10+ years of experience in clinical science or regulated healthcare environments.
• 5+ years leading clinical science teams.
• Experience with SaMD or digital health.
• Deep expertise in study design, endpoints, validation, and statistical analysis.
• Experience with FDA/CE regulatory submissions and interactions.
• Excellent written and verbal communication skills.
• Experience with wearables or digital biomarkers preferred.
• Experience interacting with regulatory bodies and CROs.

Responsibilities

• Own the clinical evidence strategy across regulated and unregulated features.
• Translate product concepts into clinically meaningful indications, endpoints, and evidence strategies.
• Define clinical validation strategies including study design and sample size justification.
• Lead feasibility, validation, and post-market studies.
• Lead clinical strategy for FDA, CE Mark, and other regulatory pathways.
• Develop, review, and approve key clinical deliverables and submission content.
• Serve as SME to stakeholders, regulators, investigators, and partners.
• Partner with Product, Data Science, Engineering, Regulatory, Quality, Legal, and Commercial teams.
• Build and lead a scalable Clinical Science organization and processes.
• Communicate complex scientific concepts to executives and teams.

Skills

Clinical science leadership

Study design

Regulatory strategy

Evidence generation

Cross-functional collaboration

Regulatory submissions

Mentoring

Regulatory interactions

Statistical analysis

Education

Advanced degree in life sciences

MPH/MS or DrPH

Tools

R

SAS

Python

SQL

CDISC

SDTM

ADaM

Job description

the company is an advanced health and fitness wearable on a mission to unlock human performance. the company 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 the company’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 the company’s clinical science capabilities, and ensure our evidence generation strategy meets the expectations of regulators, clinicians, members, and the business.

RESPONSIBILITIES:

• Own the clinical evidence strategy across the company’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.

This role is based in the the company office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

the company is an Equal Opportunity Employer and participates inE-verifyto 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.

The the company compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.

At the company, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of the company and share in the company’s long-term growth and success.

The U.S. base salary range for this full-time position is $220,000-$245,000 Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.

In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.

These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.

Learn more aboutthe company.