Janet Kube
Summary
Performance-driven Vice President with over 25 years of experience in clinical research, aligning systems with business requirements, policies and regulatory requirements. Passionate about optimizing operational delivery strategies and processes. Applying excellent organization and communication skills to manage and lead delivery-focused teams while establishing a growing market presence. Skilled in financial management and identifying strategic opportunities to improve and drive sales and revenue development.
Overview
33
33
years of professional experience
Work History
VP MedTech Operations
Premier Research Germany Ltd.
09.2023 - Current
- Developed Operating, Pricing and Proposal Models to ensure efficient and customer tailored deliverables throughout product lifecycle development within entire MedTech field
- Introduced process improvements thereby reducing operational costs while maintaining high-quality standards across all functional departments.
- Successfully integrated acquired companies / employees into existing operations without disrupting workflow or productivity.
- Collaborated closely with various department and business unit heads on strategic planning initiatives to ensure alignment with corporate goals.
- Developed and implemented new strategies and policies to establish long-term business objectives and provide strong and sustainable organizational leadership.
- Directed market expansions to propel business forward, met changing customer needs due to revised and new regulatory landscape requirements
- Developed training modules / program to promote and develop new team members including managers (also from within), building and maintaining cohesive leadership structure within the MedTech specific environment
- Increased sales numbers consistently through repeat business growth based on improved delivery strategies, as well as aggressive market campaigns, conference attendances and marketing material releases
- Communicated business performance, forecasts and strategies to C-Suite and hence Investors and shareholders
- Hired and managed new directors / managers to drive business growth.
- Cultivated a high-performance culture within the organization by setting clear expectations for employees at all levels, providing regular feedback, and recognizing achievement.
- Excellent leadership capabilities, successfully motivating and inspiring others - retention rate in past five years consistently above company and industry standard
- Skilled at working independently and collaboratively in a team environment.
Executive Director, Program Delivery
Premier Research Germany Ltd.
04.2021 - 08.2023
- Provided strategic direction for customer portfolio through key stakeholder engagement and cross-functional management
- Acted as senior liaison for MedTech customer portfolio throughout lifecycle of collaboration
- Evaluated and supported service contract negotiations from scope definition through budget creation including pricing optimization and process improvement strategies for single-service studies as well as complex global full-service programs
- Identified, recruited and allocated resources in conjunction with corporate recruitment and resourcing department
- Aligned business unit vision, goals and objectives with corporate strategies to achieve continuous strategic and financial growth
Senior Director, Program Delivery
Premier Research Germany Ltd.
03.2019 - 03.2021
- Operated at a strategic support level for MedTech customer portfolio through key stakeholder engagement and cross functional management
- Oversaw Directors and Managers in delivering projects and programs in accordance with scope, timeline and budget expectations
- Drove strategic improvements to enhance operational and organizational efficiencies
- Revamped operational plans to account for changes in the regulatory landscape of the MedTech industry due to MDR / IVDR implementation
Project Manager / Project Director
Premier Research Germany Ltd.
02.2007 - 02.2019
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
- Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
- Fostered a culture of innovation and creativity within the project team, leading to improved problem-solving capabilities and enhanced outcomes.
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
Project Manager
PharmaNet
07.2003 - 01.2007
- Ensured adherence to project deadlines, budgets and scope by coordinating internal and external team members to realize client expectations and project profitability
- Facilitated effective communication, project status reporting and regular progress reviews for internal and external key stakeholders
- Maintained compliance with appropriate SOPs, Business Guidelines and regulatory parameters
- Drove team success through shared vision and recognition of quality performance
CRA - Senior CRA
PharmaNet
07.2000 - 06.2003
- Prepared and conducted remote and on-site qualification, initiation, monitoring and close-out visits at investigative sites
- Collaborated with Clinical Lead or equivalent to enhance and proactively manage site performance including issue resolution
- Managed query resolution by facilitating appropriate communication pathways with site personnel and Data Management representatives
- Maintained project tracking systems to ensure accurate project status reporting
- Participated and presented at Investigator Meetings
- Acted as primary liaison for investigator site personnel on study related questions and concerns
CRA
PPD Development
04.1998 - 06.2000
- Responsibilities as listed for Sr CRA with support / supervision of more experienced team members
Registered Pediatric, Practical and Surgical Nurse
Cities Of Fürth/Nürnberg And Dr. Erler Kliniken
10.1990 - 03.1998
- patient care of pediatric patients on neonatal intensive care unit, oncology ward and neurological ward
- patient care of adult patients on maternity ward, cardiology ward, geriatric ward
- active surgical nurse in the operating theatre, specialized on orthopedic surgeries, emergency surgeries, hand surgeries, plastic and reconstructive surgeries
Education
High School Diploma -
Helene-Lange-Gymnasium
Fürth, Germany07.1989
Skills
- Strategic Planning
- Operating Models Development and Operational Leadership
- Organizational Development
- Employee Motivation and Performance
- Mergers and Acquisitions
- Process Improvements
- Talent Recruitment
- Program Management
- Mission and Vision
- Performance Improvement
- Cross-Functional Collaboration
Timeline
VP MedTech Operations
Premier Research Germany Ltd.
09.2023 - Current
Executive Director, Program Delivery
Premier Research Germany Ltd.
04.2021 - 08.2023
Senior Director, Program Delivery
Premier Research Germany Ltd.
03.2019 - 03.2021
Project Manager / Project Director
Premier Research Germany Ltd.
02.2007 - 02.2019
Project Manager
PharmaNet
07.2003 - 01.2007
CRA - Senior CRA
PharmaNet
07.2000 - 06.2003
CRA
PPD Development
04.1998 - 06.2000
Registered Pediatric, Practical and Surgical Nurse
Cities Of Fürth/Nürnberg And Dr. Erler Kliniken
10.1990 - 03.1998
High School Diploma -
Helene-Lange-Gymnasium
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