Director Clinical Affairs

The Mullings Group; San Francisco (CA); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Regulatory knowledge

Clinical trial management

Vendor management

Cross-functional collaboration

Problem solving

Decision making

Educación

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

Descripción del empleo

The Director of Clinical Affairs - Minimally Invasive Surgery Market (e.g., Thyroid) is responsible for planning, directing, and executing the minimally invasive surgery market portfolio. The position requires maintaining up-to-date knowledge of all applicable US and international regulations and regulatory guidance for conducting clinical trials in compliance with all sponsored protocols, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs), as well as in-depth product and clinical knowledge of indications. She/he brings strong leadership, problem-solving, and decision-making abilities.

Essential Duties and Responsibilities

• Provide operational expertise in planning, implementing, and executing clinical trials to obtain new or specific indications for the CellFX nsPFA percutaneous electrode system in accordance with project timelines, budget, and quality standards.
• Participate in discussions with cross-functional product development teams on a regular basis and create documents required for clinical readiness.
• Contribute to clinical trial design, including protocol development, informed consent forms, case report forms/procedural worksheets, questionnaires, management of trial master files, and development of timelines, milestones, and project plans/deliverables in conjunction with the research team.
• Conduct literature review for clinical documents (e.g., Report of Priors Investigation (ROPI) and Investigator Brochure (IB).
• Support training of internal staff, study investigators and other site personnel on the proper conduct of the trial and the review of specific product performance specifications.
• Ensure investigators, site personnel, and field team members or the Contract Research Organization (CRO) perform procedures and techniques properly to mitigate risks associated with study devices.
• Oversee and manage key vendors such as CROs, Core Labs and contractors.
• Ensures studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
• Ensure studies are conducted with high quality, according Procedures, Protocol(s) and Investigational Plans.
• May attend surgical procedures for training purposes.
• Problem solve and define a solution matrix for all clinical study issues as they arise.
• Manage clinical research reporting, such as reporting to regulatory authorities and clinical research oversight entities (IRB/Ethics) as necessary.
• Support Regulatory Affairs during the submission process.
• Ensures clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
• Reviews, tracks, and approves clinical trial expenses; submit monthly clinical trial accruals to accounting.
• Develop and manage budgets for clinical projects and adheres to company financial goals, including working with accounting for accrual expenses of minimally invasive surgical studies.
• Hire, manage and develop Clinical Affairs internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.

Education and Experience

• BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.
• 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 intended 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 in directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC).
• Management experience building and leading a team is a plus.