Senior Manager, Clinical Science
Description
Role Summary
The Senior Manager, Clinical Science provides clinical and scientific leadership for medical device evidence generation across the product lifecycle, from clinical evaluation and regulatory submissions through safety event management in clinical trials and real-world evidence.
This role serves as the clinical subject matter expert for assigned devices, ensuring clinical evidence support for regulatory compliance, physician adoption, and patient outcomes. The position works closely with Clinical Operations, Regulatory Affairs, Quality, and Medical Affairs. The role involves strategic planning and cross-functional team leadership projects, ensuring all activities are executed in a compliant manner.
Key Responsibilities
Clinical Evidence Strategy (Medical Device–Focused)
- Lead development and execution of Clinical Evidence Plans (CEP) aligned with product lifecycle needs in the context of EU MDR requirements.
- Translate evidence strategy into clinical protocols and Clinical Evaluation Reports (CERs).
- Ensure alignment with FDA, EU MDR/IVDR, ISO 14155, and Good Clinical Practice (GCP) requirements.
- Identify evidence gaps and recommend post-market clinical follow-up (PMCF) and real-world evidence (RWE) strategies.
Study Design & Scientific Oversight
Provide scientific leadership for device clinical studies, including:
- Feasibility, pilot, and pivotal studies
- Post-market studies, registries, and usability/human factors studies
Review and author:
- Clinical protocols and Informed Consent Forms (ICF)
- Case Report Form (CRF) assessments
- Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and Post-Market Clinical Follow-Up Plans (PMCF)
- Clinical Study Reports (CSRs) and Safety Management Plans (SMP)
- Study training materials and other relevant study documentation, including clinical trial registration
Post-Market Surveillance & Real-World Evidence
- Partner with Quality and Safety teams as the Quality Liaison for clinical trial safety events, including:
- Post-market surveillance (PMS) plans
- PMCF studies and reports
- Benefit-risk updates
- Lead capture and evaluation of safety events across all clinical studies
- Interpret complaint, vigilance, and registry data to inform risk management and product improvements.
- Support responses to Notified Bodies and regulatory authorities.
Cross-Functional Collaboration
- Collaborate with Regulatory Affairs on submissions, responses, and inspections by providing insights from a qualified healthcare professional.
- Work with Clinical Operations on the authorship and execution of safety management plans for current and future studies, and develop end-to-end processes for safety events in all clinical trials.
- Collaborate with R&D / Engineering to translate clinical insights into design improvements.
- Support Market Access and HEOR with clinical value narratives when applicable.
- Support medical education initiatives with relevant documentation as needed.
Qualifications
Education
- Degree in life sciences required
- Clinical background or applied clinical research experience strongly preferred
Experience
- 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
Core Competencies
- 8–10 years of clinical safety experience and adverse event reporting in device vigilance, clinical research, or regulatory affairs in a CRO, medical device, or pharmaceutical company
- Medical device clinical trial design (ISO 14155)
- Understanding of device risk management (ISO 14971)
- Safety and adverse event management and evaluation in clinical trials
- Clinical evaluation and benefit-risk assessment
- Post-market surveillance and real-world evidence
- Scientific and clinical trial documentation writing
- Cross-functional leadership in matrix environments
- External investigator engagement
Preferred Attributes
- Experience in sleep and respiratory therapeutic area
- Strong executive communication, presentation, and influence skills
- Ability to flex, adapt, and prioritize in a lean environment
- Strong problem-solving and critical-thinking skills while managing multiple projects
Key Success Metrics
- Successful regulatory reviews and audits
- Effective post-market evidence generation and risk mitigation
- Internal and external stakeholder satisfaction
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between $145,000.00 and $180,000.00 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.
Our Benefits and Rewards:
In addition to the expected base salary, this role is eligible to participate in Inogen’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.
Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.