Senior Manager, Clinical Science
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Job Description
Senior Manager, Clinical Science leading clinical evidence generation for medical devices throughout the product lifecycle. Collaborating with cross-functional teams to support regulatory compliance and clinical outcomes.
Responsibilities:
- Provide clinical and scientific leadership for medical device evidence generation across the product lifecycle
- Ensure clinical evidence support for regulatory compliance, physician adoption, and patient outcomes
- Lead development and execution of Clinical Evidence Plans (CEP) aligned with product lifecycle needs
- Translate evidence strategy into clinical protocols and Clinical Evaluation Reports (CERs)
- Provide scientific leadership for device clinical studies and Review and author: Clinical protocols and Informed Consent Forms (ICF)
- Collaborate with Regulatory Affairs on submissions, responses, and inspections
- Support Market Access and HEOR with clinical value narratives when applicable
- Work with Clinical Operations on the authorship and execution of safety management plans for current and future studies
Requirements:
- Degree in life sciences required
- Clinical background or applied clinical research experience strongly preferred
- 6–10+ years of experience in clinical science, medical affairs, or clinical development within medical devices
- Hands-on experience with device clinical studies and/or registries
- Post-market clinical evidence generation
- Regulatory documentation (CER, CEP, PMCF)
- Experience supporting FDA, EU MDR, and/or global regulatory interactions preferred
Benefits:
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) plan plus employer contribution and match
- Generous paid leaves such as vacation and sick leave
- Paid volunteer time
- Annual performance bonus incentive plan
- Company-sponsored benefits
- Wellbeing programs
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