Director Clinical Affairs

BioTalent; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

BioTalent is seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company.

The role is hands-on and operationally intensive, requiring leadership across design, execution, and post-market surveillance for devices and SaMD. You will drive study design, timelines, budgets, and compliance, collaborating with regulatory, product, and legal teams to enable FDA clearances and market success.

Qualifications

• Minimum B.S. Degree with 10+ years hands-on clinical operations experience in FDA-regulated medical devices or SaMD.
• Experience owning device/SaMD lifecycle from concept through post-market surveillance.
• Familiarity with biosensing devices, consumer health tech, or wellness platforms.

Responsibilities

• Own the full device/SaMD clinical lifecycle from design to trial execution and post-market surveillance.
• Lead study design in collaboration with regulatory advisors, reimbursement specialists, and KOLs.
• Oversee site activation, enrollment, monitoring, and close-out of clinical studies.
• Manage IRB/Ethics submissions and essential documents (ICFs, protocols).
• Select and oversee third-party clinical sites and investigators as primary contacts.
• Develop timelines, budgets, and risk mitigation plans; report to leadership.
• Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820) and ICH-GCP/ISO 14155.
• Manage CRO/vendor relationships and contract negotiation.
• Collaborate cross-functionally with regulatory, product, engineering, and legal teams.
• Support FDA interactions, pre-submissions, and 510(k) submissions.
• Build and scale the clinical operations function with SOPs and tracking systems.
• Maintain post-market surveillance including adverse event monitoring.

Skills

Clinical operations

FDA regulations

IRB/Ethics submissions

CRO management

cross-functional PM

Study design

Budget planning

Post-market surveillance

Regulatory filings

Education

Bachelor's degree

Job description

We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense role for someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-market surveillance — not just a single phase of the lifecycle.

What You'll Do

• Own the full device/SaMD clinical lifecycle — from early-stage study design through trial execution, final study report, and post-market surveillance
• Develop study design from scratch in close collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees
• Lead clinical study execution — feasibility, site selection, activation, enrollment, monitoring, and close-out
• Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents
• Select, qualify, and oversee third-party clinical sites and investigators as primary point of contact
• Develop study timelines, budgets, and risk mitigation plans, reporting clearly to leadership
• Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance
• Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight
• Collaborate cross-functionally with regulatory, product, engineering, and legal teams
• Support RA/QA peers on FDA interactions, pre-subs, and 510(k) submissions
• Build and scale the clinical operations function — SOPs, templates, and tracking systems
• Maintain post-market surveillance activities, including adverse event monitoring and reporting

What You're Bring

• Minimum B.S. Degree with 10+ years hands-on clinical operations experience (5+ in leadership) running trials for FDA-regulated medical devices, SaMD/digital health, or combination products
• Demonstrated experience owning a device or SaMD through the complete lifecycle — from initial concept and study design through trial completion and post-market surveillance
• Track record of building study designs from scratch alongside key internal and external stakeholders
• Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation
• Familiarity with RWE study designs and decentralized/hybrid trial models
• Startup or scale-up experience building processes from scratch
• Experience supporting breakthrough device designations or pre-sub meetings
• Experience launching studies across multiple regions/countries, with direct exposure to varying regulatory bodies and government requirements
• Track record of trials leading to FDA clearances/approvals or labeling expansions
• Experience managing third-party clinical sites end-to-end (selection through close-out)
• Proven ability authoring IRB/Ethics submissions, ICFs, and clinical protocols
• 7+ years cross-functional program management across clinical, engineering, and regulatory
• Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH-GCP, ISO 14155, and SaMD guidance
• Experience with study budgeting, vendor management, and CRO oversight