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Manager Clinical Programs Neurovascular (m/f/d)

2 months ago
Europe
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1K-5K
Founded 2004
View All Jobs 25

Description

  • Lead global and regional clinical programs from study start-up through close-out.
  • Manage, coach, and develop a team of Study Managers and oversee resource planning across multiple projects.
  • Drive cross-functional collaboration with Regulatory Affairs, Medical Affairs, R&D, Biostatistics, Data Management, Safety, Marketing, and other stakeholders.
  • Build and maintain relationships with Key Opinion Leaders, investigators, CROs, Core Labs, and other external partners.
  • Oversee study timelines, clinical data reviews, safety activities, regulatory submissions, and governance meetings such as DSMB and CEC.
  • Lead vendor selection, contract oversight, and external partner performance management.
  • Contribute to clinical protocols, CRF development, scientific publications, and clinical evidence generation.
  • Drive operational excellence through 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 in MedTech, medical devices, biotechnology, or pharmaceuticals.
  • At least 3 years of people leadership experience, with a track record of developing and leading high-performing teams.
  • 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 with KOLs, investigators, CROs, and cross-functional stakeholders in an international matrix organization.
  • Neurovascular experience is strongly preferred; Cardiovascular or other interventional medical device therapy experience is highly desirable.
  • Strategic, collaborative, and hands-on leadership style suited to 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.
  • Fluency in English and ability to work in an English-speaking environment.

Benefits

  • Annual fitness subsidy.
  • Comprehensive Employee Assistance Program for support and guidance.
  • Two weeks of paid Family Care Leave.
  • Paid time off on December 24th and 31st in addition to regular vacation days.
  • Supportive, diverse team environment that encourages personal and professional growth.
  • Comprehensive accident insurance during all business trips.

Interested in this position?

Apply directly on the company website

Apply Now

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