Director, Clinical Research (Hybrid)

Position Overview:  

The newly created Director of Clinical Development will report directly to the Senior Director of Clinical Affairs.  This position is highly collaborative and plays a critical role in our clinical strategy, planning, execution, and oversight of clinical programs for our large portfolio of innovation.  The role is focused on thought partnership by driving clinical strategy, ensuring regulatory compliance, and generating strong clinical evidence to support 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 global 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 clinical trials (feasibility, pivotal, post-market) while possess 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.  

• Ensure compliance with GCP, ISO 14155, FDA, and international regulatory requirements. 

• Requires collaboration with 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 12 years of experience in clinical development, with at least 8 years in a leadership role within the medical device industry. 

• Proven track record of successful clinical trial execution and regulatory submissions (e.g., FDA, CE Mark). 

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