Manager Clinical Programs, Neurovascular

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Penumbra, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

📋 Description

• Lead and oversee global and regional clinical programs, driving clinical strategy and successful study execution from start-up through study close-out. • Manage, coach, and develop a team of Study Managers while ensuring effective resource planning across multiple clinical projects. • Drive cross-functional collaboration with Regulatory Affairs, Medical Affairs, R&D, Biostatistics, Data Management, Safety, Marketing, and other key stakeholders. • Build and maintain strong relationships with Key Opinion Leaders (KOLs), investigators, CROs, Core Labs, and other external partners. • Oversee study timelines, clinical data reviews, safety activities, regulatory submissions, and governance meetings (e.g., DSMB/CEC). • Lead vendor selection, contract oversight, and external partner performance to ensure high-quality study delivery. • Contribute to clinical protocols, CRF development, scientific publications, and clinical evidence generation. • Drive operational excellence through continuous process improvements while ensuring compliance with ICH-GCP, QMS, and applicable regulatory requirements.

🎯 Requirements

• Bachelor's or Master's degree in Life Sciences or a related scientific discipline. • 7+ years of clinical research or Clinical Operations experience, including 5+ years within MedTech, medical devices, biotechnology, or pharmaceuticals. • At least 3 years of people leadership experience, with a proven track record of developing and leading high-performing teams. • Strong experience leading global or regional clinical programs, including clinical strategy, study oversight, vendor management, and resource planning. • Deep knowledge of ICH-GCP, CFR requirements, clinical study operations, and regulatory compliance (FDA experience is an advantage). • Experience working closely with KOLs, investigators, CROs, and cross-functional stakeholders in an international matrix organization. • Background in Neurovascular is strongly preferred; experience in Cardiovascular or other interventional medical device therapies is highly desirable. • Strategic, collaborative, and hands-on leadership style with the ability to thrive in a dynamic small- to mid-sized MedTech environment. • Proficiency with CTMS, EDC systems, Microsoft Office, Microsoft Project, and other clinical project management tools. • Willingness to travel up to 20% for investigator meetings, congresses, site visits, and internal project meetings.

🏖️ Benefits

• Stay Active - Enjoy an annual fitness subsidy to support your healthy lifestyle. • Support & Well-Being**** **- Benefit from our comprehensive Employee Assistance Program, providing guidance and support in times of need. • Family First - Receive two weeks of paid Family Care Leave to support a sick family member or in the case of bereavement. • Vacation Time - In addition to your regular vacation days, enjoy paid time off on December 24th and 31st. • A Team That Inspires - Work alongside a diverse, open-minded, and supportive team that encourages personal and professional growth. • Accident Insurance - Stay protected with comprehensive accident insurance during all business trips.