Th e newly created Director of Clinical Development will report directly to the VP, New Product Innovation . Th is position is highly collaborative and play s a critical role in clinical strategy, planning, execution, and oversight of clinical programs for our NOI program . The role is focused on thought ful 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, t h e position require s strong leadership skills, the ability to navigate complex study designs and develop ment 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 l ead cross-functional teams that collaborate to provide strategic input in the design and implementation of early feasibility clinical trials while possess ing 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 c ollaborat ion 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 1 0 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 - preferred

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:
The US base salary range for this full-time position is $183, 225.00 - $274, 837.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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