Manager, Clinical Affairs

Manager, Clinical Affairs

Location: Leesburg, VA or Allendale, NJ (Hybrid)
Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-driven team that supports surgeons during life-changing spinal procedures. We’re seeking a Manager, Clinical Affairs to lead and oversee clinical research programs that drive innovation in spine technologies. This role offers the opportunity to manage a talented team, collaborate cross-functionally, and ensure our clinical studies meet the highest global standards of quality and compliance.

What You’ll Do:

Lead, recruit, train, and manage Clinical Affairs staff, providing mentorship and career development.
Select, contract, and manage Clinical Research Organizations (CROs) and clinical consultants.
Prepare, allocate, and track clinical budgets and department resources across projects.
Develop clinical operating plans and objectives aligned with company and departmental strategy.
Oversee implementation, progress tracking, and reporting of IDE and post-market clinical trials.
Direct planning of new clinical programs and development of study protocols.
Review and approve clinical protocols, reports, and submissions to regulatory authorities, Institutional Review Boards (IRBs), and Ethics Committees (ECs).
Collaborate with Investigators and IRBs on compliance and financial matters.
Ensure accurate collection, analysis, and presentation of clinical data; approve Case Report Forms and study databases.
Maintain and develop department Standard Operating Procedures (SOPs), ensuring compliance with regulations, corporate policies, and Good Clinical Practices (GCPs).
Oversee preparation and submission of clinical regulatory documentation (IDE submissions, IRB/EC submissions, etc.).
Author or review Clinical Evaluation Plans, Reports, Post Market Clinical Follow-Up plans and reports, and Summary of Safety and Clinical Performance (SSCPs) required for CE marking.

What You Bring:

Education:
- Bachelor’s degree required (science or health-related field such as Biology, Nursing, or Biomedical Sciences preferred).
- Advanced degree and/or ACRP or SoCRA certification preferred.
Experience & Qualifications:
- 5+ years of clinical experience required, with strong preference for experience managing IDE and post-marketing medical device trials.
- Proven leadership and people management experience.
- Expertise in FDA regulations, ICH GCP guidelines, and EU MDD/MDR, MEDDEV 2.7.1 Rev. 4, and ISO 14155.
- Experience preparing and submitting IDEs, PMAs, and conducting FDA meetings.
- Background in developing and maintaining department SOPs.
- Ability to work effectively with cross-functional partners, including other divisions and corporate teams.
- Strong analytical, communication, and project management skills.
Physical & Mental Requirements:
- Ability to handle multiple concurrent tasks and shifting priorities.
- Strong attention to detail and independent judgment.
- Skilled in facilitating discussions, presenting to groups, and managing communications.
- Proficiency in Microsoft Office Suite and related systems.
- Must be able to occasionally lift up to 20 lbs; visual acuity required for close work.

Why VB Spine?

At VB Spine, we believe in growing talent from within. Join a collaborative, high-performing team where your work directly impacts patient outcomes. Benefit from mentorship, continuous learning, and the opportunity to shape clinical strategy in an innovative medical device company.

Compensation:

Pay for this role is competitive and based on experience. The typical range for this position is $155,000 - $175,000 annually, plus potential bonuses and incentives. Final compensation is determined on a case-by-case basis and considers factors including experience, qualifications, and market conditions.

Benefits include:

Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast-paced, dynamic company

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