Penumbra - Manager Clinical Programs Neurovascular (m/f/d)

Europe1w ago

In Office Mid EMEA Medical Devices Pharmaceuticals Clinical Director Team Management Coaching Program Management GCP Vendor Management Regulatory Compliance Microsoft Office Close Regulatory Affairs Cross-functional Collaboration Governance

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. • As we require fluently English skills and the process will involve English speaking colleagues, we are looking forward to receiving your CV in English. • At Penumbra, we value your skills and qualifications above all else. We welcome candidates of any gender, ethnicity, religion, sexual orientation, or age. If you're skilled and a good match for our culture of collaboration, we want you on our team.

Responsibilities

• 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.