Director, Clinical Operations

United States Digital Space LLC; Boston (MA); On-site; USD 210,000 - 230,000; Full time

Job summary

United States Digital Space LLC is seeking a Director, Clinical Operations in Boston, MA to lead the clinical operations function for regulated and unregulated health features, including SaMD. You will own operational strategy and study execution across the product lifecycle, from feasibility to post-market evidence generation.

You will build a high‑performing Clinical Operations organization, oversee CROs and internal studies, and ensure high‑quality, compliant execution meeting regulator

Qualifications

• Own the clinical operations strategy across regulated and unregulated features.
• Develop and execute models for internally executed and CRO‑managed studies.
• Partner with Clinical Science to align study execution with timelines and budgets.
• Lead study startup, planning, execution, and closeout activities.
• Oversee participant recruitment, enrollment, retention, and data collection.
• Establish governance with vendors and external partners.

Responsibilities

• Lead and mentor a Clinical Operations organization across multiple portfolios.
• Ensure studies comply with GCP, FDA regulations, and ISO 14155.
• Manage budgets, vendor contracts, and resource forecasting.
• Oversee study startup activities including IRB/ethics submissions.
• Communicate progress and risks to executive leadership.
• Support regulatory submissions and inspections.

Skills

Clinical operations strategy

Decentralized trials (DCT)

Vendor management

CRO oversight

Regulatory compliance

Cross-functional leadership

Education

Bachelor’s degree

Advanced degree (MS/MPH/MBA etc.)

Tools

EDC

CTMS

eConsent

ePRO

eTMF

Job description

As the Director, Clinical Operations, you will lead the clinical operations function responsible for executing the studies that support the company’s regulated and unregulated health features, with a particular focus on Software as a Medical Device (SaMD). You will own operational strategy and study execution 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 clinical trial operations, decentralized clinical trials, vendor oversight, and operational execution within regulated healthcare environments. As both a strategic leader and hands‑on expert, you will oversee studies conducted through CROs as well as internally executed studies, ensuring high‑quality, efficient, and compliant execution across the company’s clinical portfolio.

You will build and mentor a high-performing Clinical Operations organization. You will strengthen the company’s clinical operations capabilities and ensure our study execution strategy meets the expectations of regulators, investigators, participants, and the business.

QUALIFICATIONS:

• Own the clinical operations strategy across the company’s portfolio of regulated and unregulated health features, including feasibility, validation, regulatory submission, launch, and post-market evidence generation.
• Develop and execute fit‑for‑purpose operational models for both internally executed studies and CRO‑managed validation studies, ensuring efficient evidence generation across the product lifecycle.
• Partner with Clinical Science and cross‑functional leadership to develop study execution strategies, resource plans, vendor models, and operational timelines that balance speed, quality, cost, and regulatory requirements.
• Lead study startup, planning, execution, monitoring, and closeout activities, ensuring timelines, budgets, enrollment targets, quality objectives, and regulatory requirements are achieved.
• Oversee participant recruitment, enrollment, retention, study logistics, and data collection activities across both internally executed and externally managed studies.
• Lead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high‑quality delivery and accountability.
• Build and oversee capabilities for internally executed studies, including decentralized clinical trials (DCTs), feasibility studies, algorithm development studies, and product research initiatives.
• Oversee Clinical Data Management and clinical trial technologies, ensuring high‑quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
• Oversee study startup and regulatory operations activities, including feasibility assessments, investigator and site selection, IRB and Ethics Committee submissions, global ethics approvals, essential document management, study activation, and Trial Master File inspection readiness.
• Ensure studies are conducted in accordance with GCP, FDA regulations, ISO 14155, company procedures, and quality requirements, while supporting audits, inspections, and regulatory submissions.
• Build and lead a high‑performing Clinical Operations organization, including hiring, mentoring, workforce planning, and establishing scalable processes, standards, and operating models.
• Communicate study progress, operational risks, vendor performance, and portfolio status to executive leadership and key stakeholders.

RESPONSIBILITIES:

• Bachelor’s degree required; advanced degree (MS, MPH, MBA, RN, PharmD, PhD, or equivalent) preferred.
• 10+ years of experience in clinical operations, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
• 5+ years of experience leading multidisciplinary clinical operations teams, including Clinical Trial Management, Clinical Monitoring, Clinical Data Management, Study Startup, and Clinical Operations functions.
• Demonstrated experience overseeing CRO‑managed clinical studies and external vendor partnerships.
• Experience leading internally executed clinical research programs, including decentralized clinical trials, participant‑facing operations, site management, direct‑to‑participant research, or hybrid study models.
• Deep expertise in clinical trial execution, study startup, participant recruitment, monitoring, enrollment, clinical data management, trial master file oversight, and study closeout activities.
• Experience managing clinical study budgets, vendor contracts, resource forecasting, and portfolio planning.
• Strong understanding of GCP, FDA regulations, ISO 14155, IRB/Ethics Committee processes, and medical device clinical research requirements.
• Excellent written and verbal communication skills, with the ability to translate complex operational, clinical, and regulatory concepts for diverse audiences.

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

The U.S. base salary range for this full‑time position is $210,000-$230,000 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.