Clinical Team Lead

Walker Cole International; United States; Remote; GBP 90,000 - 130,000; Full time

Job summary

Walker Cole International is recruiting for a Clinical Lead to own clinical strategy and deliver clinical, PMCF and HFE studies for a leading medical device manufacturer. You will lead a team of clinical specialists and collaborate with cross-functional teams to ensure robust clinical evidence supports product claims and regulatory submissions.

The role requires an experienced clinical affairs professional with strong leadership, budget management, and regulatory writing skills.

Qualifications

• A degree in a life science, clinical or healthcare discipline, with significant clinical affairs or clinical research experience in medical devices.
• Proven experience authoring and approving CERs and PMCF plans and reports under EU MDR.
• Experience leading clinical and/or HFE studies end to end, including budgets, vendors and CROs.
• Working knowledge of ISO 13485, ISO 14155, ISO 14971, FDA requirements, MDD and MDR.

Responsibilities

• Set clinical strategy for assigned products and portfolios, acting as the clinical subject-matter authority.
• Lead, mentor and develop clinical specialists to ensure quality of deliverables.
• Own delivery of clinical, PMCF and HFE studies to budget, scope and schedule.
• Prepare and approve CERs, clinical evaluation plans and PMCF plans and reports under EU MDR 2017/745.
• Manage clinical budget and external vendor relationships (CROs, sites).
• Define clinical requirements and options for regulatory submission pathways.
• Provide clinical guidance on product claims, labeling and design changes.

Skills

Clinical leadership

People management

Budget management

Regulatory knowledge

Technical writing

Project management

Regulatory submissions

Communication

Education

Life science/healthcare degree

Job description

Clinical Lead Walker Cole International is proudly supporting a leading medical device manufacturer to appoint a Clinical Lead.

Location: Remote

In this position you’ll act as the clinical point of authority for the business, owning clinical strategy and the delivery of clinical, PMCF and human factors engineering (HFE) studies from protocol design through to final report. You’ll lead a team of clinical specialists and partner closely with cross-functional teams to ensure products are supported by robust clinical evidence. The position suits a clinical affairs professional who enjoys combining technical and scientific expertise with people leadership and commercial ownership, and who is confident making independent decisions with minimal supervision.

What you’ll be doing:

• Setting clinical strategy for assigned products and portfolios, and acting as the clinical subject-matter authority to the business.
• Leading, mentoring and developing clinical specialists, ensuring consistent quality of clinical deliverables.
• Owning the delivery of clinical, PMCF and HFE studies to budget, scope and schedule.
• Leading the preparation and approval of CERs, clinical evaluation plans and PMCF plans and reports under EU MDR 2017/745.
• Managing the clinical budget and pricing strategy, along with external vendors, CROs and clinical sites.
• Defining clinical requirements and options for regulatory submission and approval pathways.
• Providing clinical guidance on product claims, labelling and design changes, including regulatory filing impact.
• Leading the development and continuous improvement of clinical SOPs.
• Representing the clinical function in notified body, regulatory and audit interactions.
• A degree in a life science, clinical or healthcare discipline, with significant clinical affairs or clinical research experience in medical devices.
• Proven experience authoring and approving CERs and PMCF plans and reports under EU MDR.
• A track record of managing clinical and/or HFE studies end to end, including budgets, vendors and CROs.
• Working knowledge of ISO 13485, ISO 14155, ISO 14971, FDA requirements, MDD and MDR.
• Strong project management and technical writing skills.
• Confident communication and influencing skills, including with senior management.
• Experience leading or line managing a team.
• Experience of notified body and regulatory authority interactions on clinical matters.
• Experience developing clinical strategy and clinical SOPs.
• Experience working internationally in a fast-paced, entrepreneurial environment.

Clinical Lead | Clinical Affairs | Clinical Evaluation | CER | PMCF | Human Factors | HFE | EU MDR | ISO 14155 | ISO 13485 | Medical Devices