Director, Device Clinical Affairs
Biogen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $178,000 - $245,000 per year
Job Level
About the role
- Lead the execution of device clinical studies, ensuring compliance with applicable regulations and internal procedures.
- Manage relationships with subject matter experts, key opinion leaders, and investigators to support high-quality clinical data and submissions.
- Provide clinical input and oversight for regulatory strategy and submissions, including verification and validation activities.
- Oversee CRO relationships to ensure delivery against timelines, quality, and regulatory requirements.
- Ensure compliance of product labeling and promotional materials with regulatory requirements.
- Facilitate cross-functional alignment to achieve clinical program objectives.
- Address complex operational or protocol issues requiring senior clinical judgment.
- Travel to scientific meetings and clinical sites as needed, both domestically and internationally.
Requirements
- Bachelor’s degree and a minimum of 12 years’ experience managing clinical studies.
- In lieu of required educational degree, candidates with a minimum of 6 years supervisory experience in a healthcare or clinical research setting with ACRP/SOCRA certification and a minimum of 4 years of relevant clinical research experience in a pharmaceutical device company/CRO may also be considered.
- Experience with US FDA and European regulatory authorities.
- High level of organizational and project management skills with ability to work collaboratively in a fast-paced, team-based matrix environment.
- Excellent written and verbal communication skills.
- Proven success in building relationships with stakeholders such as Clinical Operations, Regulatory, Biostatistics, and clinical investigators.
- Ability to travel for scientific meetings and site visits as needed (domestic and international).
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical studies managementregulatory strategyverification and validation activitiesproject managementclinical data submissionscompliance with regulationsproduct labeling complianceprotocol issue resolutionCRO managementclinical research experience
Soft Skills
organizational skillscollaborative skillscommunication skillsrelationship buildingleadershipjudgmentteamworkproblem-solvingadaptabilityinterpersonal skills
Certifications
ACRP certificationSOCRA certification