Sr Clinical SaMD Consultant

Ideal Consultant Profile

The ideal candidate should be a senior to executive-level clinical operations leader with experience developing and overseeing clinical trial strategies for emerging medical technology, digital health, SaMD, or device-related programs. This person should be comfortable working at both the strategic and executional levels, including identifying risks, building operational plans, advising leadership, and overseeing CRO performance.

The candidate should have experience managing complex stakeholders, including internal technical teams, regulatory consultants, CROs, investigators/sites, boards, and investors. They should be able to communicate effectively with executive leadership and provide practical, business-minded recommendations that support both development milestones and investor confidence. Experience with SaMD is important, and experience in obstetrics, maternal health, women’s health, or related clinical areas would be highly desirable.

The consultant does not need to replace the existing regulatory or technical experts but should be able to understand the regulatory and clinical development pathway well enough to identify operational dependencies, gaps, sequencing issues, and execution risks.

Key Experience Needed

• Senior clinical operations leadership experience, ideally at the director, VP, or executive consultant level
• Experience creating clinical operational strategies and development execution plans
• Ability to conduct a cross-functional gap analysis across regulatory, operational, site, CRO, vendor, and execution workstreams
• Strong CRO selection, CRO oversight, and vendor management experience
• Experience supporting early-stage or emerging company environments where infrastructure may still be developing
• Familiarity with SaMD, digital health, medical device, or technology-enabled clinical development programs
• Ability to work with technical, regulatory, clinical, investor, board, and CRO stakeholders
• Strong risk identification, mitigation planning, governance, and operational oversight capabilities
• Obstetrics, maternal health, women’s health, or related therapeutic experience preferred

Summary of Need

In short, the candidate needs a senior strategic clinical operations consultant who can quickly assess the current development and execution plan, identify any gaps or risks, create a practical operational strategy, and then provide part-time ongoing oversight to help ensure the plan is implemented effectively. The right person should bring enough seniority and credibility to advise leadership, challenge assumptions, guide CRO/vendor performance, and support communication with boards or investors as needed.