Senior Staff Clinical Evaluation Specialist (Remote)

About the role

For our client, we are seeking a Senior Staff Clinical Evaluation Specialist to join the team of a leader in the Pharmaceuticals & Biotech space. In this remote role, you will lead the development of clinical evidence strategies that support new products and lifecycle management across a regulated healthcare environment. You will partner closely with regulatory, quality, and cross-functional stakeholders to align clinical evidence, submissions, and commercialization goals. This position also offers the opportunity to mentor team members, strengthen clinical evaluation processes, and contribute to scientific communication efforts.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead development of clinical evidence strategies for new products and lifecycle management.
• Manage clinical evaluation projects aligning evidence, regulatory strategy, and commercialization goals.
• Author and maintain clinical evaluations, regulatory submissions, and safety performance reports.
• Design and execute literature reviews and synthesize clinical and preclinical data.
• Assess benefit-risk profiles and develop evidence-based recommendations per global regulations.
• Collaborate with regulatory authorities and stakeholders to address clinical evidence needs.
• Mentor team members and enhance clinical evaluation methodologies.

Qualifications

• Master's degree in health, clinical, biological science, biomedical engineering, or a related field.
• 6+ years of experience in clinical affairs, regulatory affairs, quality, or related medical device roles.
• 2+ years of experience authoring clinical evaluations for medical devices.
• Proficiency in conducting literature reviews and synthesizing scientific evidence.
• Experience supporting regulatory submissions in a regulated healthcare environment.
• Fluency in English.

Benefits

• Flexibility to work remotely or hybrid.
• Opportunity to lead and influence clinical evidence strategies.
• Collaboration with diverse teams across the organization.
• Mentorship opportunities within a senior role.
• Potential involvement in scientific publications and presentations.

Pay

$110,100 – $183,400 annually