About This Role: 

As the Director of Device Clinical Affairs, you will lead the strategic and operational efforts for clinical programs centered around implantable medical devices. Your role is pivotal in ensuring that studies are conducted to the highest scientific, regulatory, and quality standards. You will oversee complex, multiphase clinical development strategies, from startup to closeout, guiding decision-making that influences program direction and regulatory success.

Collaborating with teams across Regulatory, Quality, Engineering, Medical Affairs, Marketing, and external partners, you will provide critical clinical evidence and insights for regulatory submissions, labeling, human factors studies, and verification/validation activities. Your expertise will be key in bringing innovative medical device solutions to market, enhancing patient care and outcomes.

What You’ll Do:

• 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.

Who You Are: 

You are a clinical affairs leader with deep expertise in medical device clinical trials, providing oversight and guidance for the execution of complex clinical trials. You bring a strong command of IDE and GCP requirements and apply rigorous clinical judgment to ensure protocol adherence, patient safety, and data integrity. You interpret regulatory requirements, protocols, and safety considerations at a program level and guide teams in their application. You lead complex, nuanced discussions with investigators, site staff, and CRO partners, translating a wide range of inputs into clear, objective, and actional conclusions that inform sound decision-making.

Required Skills:

• 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).

Preferred Skills:

• Master’s degree in life sciences, nursing, or related allied health profession.

• Certification with ACRP/SOCRA or willingness to acquire.

• Experience in a pharmaceutical device company or clinical research organization.

 

Job Level: Management

Additional Information

The base compensation range for this role is: $178,000.00-$245,000.00