Director/Sr Director, Clinical Affairs

BioTalent; San Francisco (CA); On-site; USD 180,000 - 250,000; 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. This hands-on role covers concept through trial completion and post-market surveillance, requiring leadership across internal teams and external partners.

You will design studies, lead site activation and enrollment, manage IRB submissions, and ensure FDA/ICH compliance while scaling the clinical operations function for multiple regions.

Qualifications

• 10+ years in hands-on clinical operations for FDA-regulated devices or SaMD.
• Experience owning device/SaMD lifecycle from concept to post-market.
• Ability to design studies with internal and external stakeholders.

Responsibilities

• Own full clinical lifecycle from design to trial execution and post-market surveillance.
• Develop study designs with internal teams and external advisors.
• Lead site selection, activation, enrollment, monitoring, and close-out.
• Manage IRB submissions, informed consent, and essential documents.
• Oversee third-party sites and investigators as primary contact.
• Develop timelines, budgets, and risk mitigation for leadership.
• Ensure compliance with FDA regs, ICH-GCP, ISO 14155, SaMD guidance.
• Manage CRO relationships and vendor performance; negotiate contracts.
• Collaborate with regulatory, product, engineering, and legal teams.
• Support FDA interactions and 510(k) submissions; scale clinical ops SOPs.
• Maintain post-market surveillance including adverse event reporting.

Skills

Clinical operations

Regulatory affairs

Cross-functional leadership

FDA regulations

Vendor management

Trial design

Education

B.S. Degree

Tools

CRO management

IRB/Ethics submissions

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 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