Team Lead, Clinical Science

Overview

This position provides leadership for the Clinical Science team while continuing to perform clinical scientist-level responsibilities for assigned studies. The Team Lead, Clinical Science supervises members of the Clinical Science team, setting team goals and priorities, guiding day-to-day work, and providing peer review and mentorship. This position partners closely with clinical leadership on staffing and performance management.

Responsibilities

Supervise and lead a team of Clinical Scientists and/or Clinical Science Analysts; set team goals, priorities, and work assignments in support of departmental objectives;

Perform clinical scientist duties for any assigned studies, including clinical data strategy development, study design input, analysis, interpretation, and reporting of clinical and imaging data;

Provide technical and scientific guidance and peer review of team members' study design, data analysis, and reporting deliverables prior to stakeholder or regulatory submission;

Partner with clinical leadership on resource planning, workload allocation, and day-to-day staffing decisions for the team;

Lead the onboarding and training of new Clinical Science team members;

Facilitate goal setting, ongoing feedback, and the annual performance review process for direct reports; provide primary input on performance ratings, promotion recommendations, and reward decisions;

Maintain ongoing communication with direct reports through team meetings, one-on-ones, and other appropriate channels; foster an environment where feedback is encouraged;

Consult Human Resources on employee relations matters, including documentation and resolution of disciplinary actions when required;

Ensure team activities comply with quality systems procedures, GCP, ISO 14155, and other applicable clinical systems and regulatory standards;

Identify opportunities to improve clinical science processes and participate in global clinical function process improvement initiatives;

Review and approve direct reports' routine administrative requests (e.g., expense reports, PTO, purchase orders) in accordance with company policy; and

Serve as a point of contact between the Clinical Science team and cross-functional stakeholders, communicating team priorities, policies, and practices as needed.

Qualifications

Bachelor's degree in Life Sciences, Engineering, or a closely related field required; advanced degree (Master's or PhD) preferred;

Minimum 7 years of clinical research experience, including experience mentoring, training, or informally leading others;

Working knowledge of GCP guidelines, ISO 14155, and applicable FDA and international regulatory requirements for medical devices;

This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers;

Demonstrated ability to balance individual clinical science responsibilities with supervisory leadership of a team;

Strong analytical skills with demonstrated ability to interpret complex clinical and imaging datasets and review the work of others;

Working knowledge of the regulatory authorities and requirements that may impact global clinical studies;

Proven leadership, coaching, and mentoring abilities; skilled at setting goals, delivering feedback, and developing talent;

Excellent written, listening, and verbal communication skills; sufficiently assertive to navigate difficult conversations diplomatically;

Sound judgment in independent decision-making, with appropriate escalation to clinical leadership;

Excellent organizational and problem-solving skills; ability to manage multiple projects, responsibilities, and deadlines for self and team;

Willingness and ability to travel up to 15% of the time;

This position is eligible for either hybrid or remote work status.