Director, Clinical Affairs

About the role

The Director of Clinical Affairs is a leader responsible for defining and driving the integrated clinical and medical strategy across the product lifecycle for one or more therapeutic areas or platforms. This role provides end-to-end accountability for clinical evidence generation and external scientific engagement, ensuring alignment with corporate, commercial, and cross-functional objectives. The Director serves as a key strategic advisor to senior leadership and represents the organization to external stakeholders. This role reports to the Vice President, Medical Affairs and manages Clinical resources, operating as a distinct clinical evidence function within Medical Affairs.

Strategic Clinical Leadership

• Develops and executes a comprehensive clinical evidence strategy aligned with organizational objectives
• Anticipates future clinical, regulatory, and market needs while translating scientific insights into actionable business strategies

Clinical Operations & Execution Excellence

• Leads the successful planning, execution, and oversight of clinical studies, ensuring projects are delivered on time, within budget, and in compliance with GCP, regulatory requirements, and quality standards

Cross-Functional Collaboration & Influence

• Builds strong partnerships across Medical Affairs, Regulatory, R&D, Product, Commercial, and external stakeholders
• Effectively influences decision-making and aligns diverse teams around shared clinical and business objectives

People Leadership & Talent Development

• Builds, develops, and inspires high-performing teams by setting clear expectations, fostering accountability, providing coaching, and creating an environment of scientific excellence, collaboration, and continuous growth

External Scientific Engagement

• Establishes and maintains trusted relationships with investigators, key opinion leaders (KOLs), regulatory agencies, and scientific organizations
• Represents the company with credibility and leverages external insights to strengthen clinical strategy

Results Orientation & Agility

• Demonstrates a hands-on, solution-oriented approach in a fast-paced environment by effectively prioritizing competing demands, navigating ambiguity, and driving execution while maintaining high standards of quality and integrity

Clinical & Evidence Strategy Ownership

• Own and define the end-to-end clinical evidence strategy across pre-market and post-market phases
• Develop integrated evidence generation plans aligned with regulatory, product development, and commercialization objectives
• Identify evidence gaps and prioritize studies to support approvals, adoption, and differentiation
• Translate clinical insights into actionable recommendations to inform product and business strategy

Clinical Study Leadership & Execution

• Lead the design, execution, and oversight of clinical studies, including protocol development and endpoint selection
• Direct end-to-end study operations, including: CRO/vendor selection and management, site and investigator engagement, data collection, monitoring, analysis, and reporting
• Oversee development of clinical study reports (CSRs) and publication plans
• Ensure compliance with GCP, regulatory requirements, and internal SOPs
• Maintain accountability for timelines, budgets, quality, and study outcomes

Clinical Infrastructure & Capability Building (Startup Focus)

• Build and scale clinical research infrastructure, processes, and systems
• Establish fit-for-purpose SOPs, workflows, and governance frameworks
• Develop efficient operating models leveraging internal teams and external partners
• Ensure organizational readiness for regulatory submissions, inspections, and audits

External Scientific Engagement

• Develop and maintain relationships with investigators, KOLs, and clinical experts
• Represent the company in regulatory interactions, investigator meetings, and advisory boards
• Generate and synthesize insights from external stakeholders, literature, and congresses to inform strategy
• Contribute to shaping the external scientific and clinical landscape through credible engagement

People Leadership

• Lead and develop a high-performing clinical team, including consultants, and vendor partners
• Coach and guide the clinical team in consistently achieving their goals in support of the overall company goals
• Set clear goals, priorities, drive accountability, and foster a culture of scientific excellence and agility
• Conduct performance evaluations in accordance with the company's policies

Cross-Functional Leadership

• Act as a core partner and work collaboratively with Commercial, Quality & Regulatory, R&D, Product, Marketing and other key functional teams within the organization
• Ensure clinical strategy is tightly aligned with regulatory and business priorities
• Provide clinical input into product development, labeling, positioning, and market access discussions
• Support regulatory submissions with robust and defensible clinical evidence

Selective Medical Affairs Integration

• Collaborate with Medical Affairs on: medical insights generation, scientific communications and publications, medical education and congress operations (as appropriate)
• Provide scientific oversight of clinical content to ensure accuracy, integrity, and compliance
• Maintain clear separation of clinical evidence generation from promotional activities

Compliance & Quality

• Ensure all clinical activities adhere to GCP, regulatory requirements, and internal policies
• Oversee adverse event reporting and safety monitoring within clinical studies
• Support quality systems and inspection readiness

Qualifications

• Master's degree or equivalent in a scientific discipline with a minimum of 8-10 years' experience in progressively responsible clinical affairs roles in the medtech, biotech industries or related field required
• 3-5 years of management experience
• 8+ years in clinical research, evidence generation, and/or medical affairs experience is required

Skills

• Ability to build and execute clinical programs in a start-up or high-growth environment
• Ability to develop, lead a team of professionals and provide constructive feedback in a professional and timely manner
• Solid knowledge and background of clinical trials, study design
• Strong understanding of trial planning and design, operationalization, and regulatory expectations
• Strategic thinker with strong execution capability and a hands-on leadership style
• Demonstrated ability to influence cross-functional stakeholders and operate in ambiguity
• Strong external engagement experience with investigators, KOLs, and regulators
• Proven ability to manage competing priorities across multiple projects in a fast-paced, dynamic environment
• Familiarity with regulated quality systems (CLIA, CAP, ISO 13485, Design Control, GMP, and 21 CFR 820)
• Experience supporting FDA or Notified Body audits is preferred
• Exceptional written and verbal communication skills; ability to collaborate cross-functionally with senior leadership and scientific staff
• Able to travel 40% of the time
• "Do what it takes – no job is too small" team player and a positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed
• A team player who is curious, adaptable, and willing to learn new techniques or concepts
• Organizational skills, attention to detail, and ability to multi-task are excellent
• A proactive problem-solver who takes ownership of assigned tasks
• Likes building effective internal relationships including with team members, clients, vendors, suppliers, and team members

Physical Demands

• Employee is required to stand; walk, sit, bend, reach and use hands to finger, handle or feel
• May occasionally lift and/or move up to 25 pounds
• Able to talk or hear
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day
• Travel about 40% of the time