Director, Clinical Affairs — Minimally Invasive Trials

The Mullings Group; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

The Mullings Group is seeking a Director of Clinical Affairs for the Minimally Invasive Surgery market (e.g., Thyroid) in San Francisco. Lead planning, execution, and regulatory alignment for clinical trials and product indications, ensuring adherence to GCP and SOPs.

You will guide cross-functional teams, design trials, manage budgets, and oversee CROs and vendors, with a focus on high-quality data for regulatory submissions and publications.

Qualifications

• 10+ years of progressive industry experience with a medical device company.
• 5+ years clinical trial management experience with class II and class III medical devices.
• Experience in managing clinical trials using ablation devices to treat soft tissue tumors and/or nodules is a plus.
• Experience in conducting multi-center IDE clinical trials or pivotal clinical studies to support FDA approvals.
• Experience in writing the clinical section of a 510k and/or PMA application to the FDA is a plus.
• Strong hands-on experience directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC).
• Management experience building and leading a team is a plus.

Responsibilities

• Provide operational expertise in planning, implementing, and executing clinical trials to obtain new or specific indications for the CellFX nsPFA percutaneous electrode system.
• Participate in discussions with cross-functional product development teams and create documents for clinical readiness.
• Contribute to clinical trial design, including protocol development, informed consent forms, CRFs, and study timelines.
• Conduct literature reviews for clinical documents (ROPI, IB).
• Support training of internal staff, investigators, and site personnel on trial conduct and performance specs.
• Ensure investigators and site personnel perform procedures properly to mitigate device risks.
• Oversee and manage key vendors such as CROs and Core Labs.
• Ensure studies stay on track for site initiation and patient recruitment; take corrective actions as needed.

Skills

Leadership

Regulatory knowledge

Clinical trial management

Vendor management

Cross-functional collaboration

Problem solving

Decision making

Education

Life Sciences degree (BS/BA/BSN/RN or higher)

Job description

The Mullings Group is seeking a Director of Clinical Affairs for the Minimally Invasive Surgery market (e.g., Thyroid) in San Francisco. Lead planning, execution, and regulatory alignment for clinical trials and product indications, ensuring adherence to GCP and SOPs.

You will guide cross-functional teams, design trials, manage budgets, and oversee CROs and vendors, with a focus on high-quality data for regulatory submissions and publications.