Director, Clinical Affairs, New Innovation (Onsite)

The newly created Director of Clinical Development will report directly to the VP, New Product Innovation.  This position is highly collaborative and plays a critical role in clinical strategy, planning, execution, and oversight of clinical programs for our NOI program.  The role is focused on thoughtful partnership by driving NOI clinical strategy, ensuring regulatory compliance, and generating clinical evidence to support further product development, regulatory submissions, and market access.  The position requires a deep understanding of medical device regulations.  In addition, the position requires strong leadership skills, the ability to navigate complex study designs and development of robust strategies.   

Responsibilities: 

Clinical Strategy & Leadership 

• Develop and execute NOI clinical development strategies aligned with corporate objectives

• Leads others to solve complex problems by taking a broad perspective to identify solutions

• Accountable to lead cross-functional teams that collaborate to provide strategic input in the design and implementation of early feasibility clinical trials while possessing a deep breadth of expertise

• Leads difficult concepts and negotiates with others to align on a shared point of view

• Serve as the clinical subject matter expert in interactions with regulatory bodies, KOLs, and internal stakeholders

Trial Design & Execution 

• Lead strategy in study needs by contributing robust strategic design and execution

• Compliance with GCP, ISO 14155, FDA, and international regulatory requirements

• Requires collaboration with Medical Affairs and clinical operations teams to ensure timely and budget-conscious delivery of clinical studies

Data & Evidence Generation 

• Collaborate with biostatistics, medical writing, and regulatory teams to ensure high-quality deliverables. 

Team Development & Management 

• Build and mentor a high-performing clinical development team

• Foster a culture of innovation, accountability, and continuous improvement

Education and Experience: 

• Advanced degree (MD, PhD, PharmD, or equivalent) in life sciences, medicine, or related field

• Minimum of 10 years of experience in clinical development, with at least 8 years in a leadership role within the medical device industry or clinical research organization

• Track record of successful clinical trial execution and regulatory submissions (FDA, CE Mark)

• Understanding of clinical trial design, biostatistics, and regulatory requirements

• Strong leadership, communication, and cross-functional collaboration skills

• Global clinical trial experience (EU, APAC, LATAM) - preferred

• Diabetes experience - p