VIce President, Clinical Affairs
Title: Vice President, Clinical Affairs
Company: Medical Device - Orthopedic Robotics
Location: Remote (United States)
Overview:
Our team is seeking a Vice President of Clinical Affairs to lead the global clinical function. This role will take ownership of clinical strategy and execution across a portfolio of robotic surgical technologies, supporting both regulatory progression and broader commercial objectives.
This is a senior leadership position with direct visibility to executive stakeholders and responsibility for building clinical capability as programs advance.
Role Summary:
The Vice President of Clinical Affairs will be responsible for defining clinical strategy, overseeing study execution, and ensuring alignment with regulatory and product development priorities.
The position will work closely with cross-functional leadership, including Regulatory Affairs, R&D, Quality, and Commercial teams, to ensure clinical evidence plans are aligned with overall business objectives.
Key Responsibilities
Clinical Strategy & Leadership
- Define and implement the global clinical strategy across orthopedic robotics programs
- Ensure clinical plans are aligned with regulatory pathways, product milestones, and market access requirements
- Act as the clinical lead within the leadership team, contributing to broader strategic decisions
Clinical Trial Execution
- Oversee all clinical studies including early feasibility, IDE, pivotal, and post-market activities
- Ensure studies are designed and executed in line with regulatory expectations (FDA and international)
- Drive timelines, budgets, and operational delivery across clinical programs
Regulatory & Evidence Generation
- Partner with Regulatory Affairs to support submissions including IDE, 510(k), PMA, and CE Mark
- Ensure clinical data packages meet requirements for global approvals and labeling claims
- Support development of evidence to enable reimbursement and market adoption
External Engagement
- Build and maintain relationships with key opinion leaders (KOLs) in orthopedic surgery and robotics
- Oversee site selection, investigator engagement, and clinical partnerships
- Represent the organization in interactions with regulatory authorities and external stakeholders
Cross-Functional Collaboration
- Work closely with R&D on clinical input into product development and study design
- Partner with Commercial and Marketing to translate clinical data into value messaging
- Support Quality and Compliance activities related to clinical programs
Team Leadership
- Build, scale, and lead the Clinical Affairs organization
- Manage internal team members and external CRO partners
- Establish processes and systems to support clinical operations as the company scales
Experience & Requirements:
- 12+ years of experience within medical devices, with a focus on Clinical Affairs
- Prior leadership experience at Director or VP level
- Background in orthopedics, surgical devices, or robotic-assisted technologies
- Demonstrated experience leading clinical programs through IDE and pivotal stages
- Strong understanding of FDA regulatory pathways (IDE, 510(k), PMA) and global clinical requirements
- Experience managing multicenter clinical trials
- Track record of building and leading clinical teams
- Strong communication skills with the ability to engage internal and external stakeholders
Additional Considerations:
- Experience in early-stage or growth-stage medical device environments is preferred
- Familiarity with global trial execution outside the U.S. is beneficial
- Ability to operate in a cross-functional, fast-moving setting
Opportunity:
- Leadership role with responsibility for shaping clinical strategy
- Direct interaction with executive team and key decision-makers
- Involvement in programs at a critical stage of development
- Compensation package including base salary, bonus, and equity
Next Steps
For further information or a confidential discussion, please apply directly.