Ute Dr. rer. nat. Simon neé. Bögemann
Fürth
Summary
Senior Medical Leader with 20+ years in pharma, leading global clinical operations, medical affairs, and strategic development. Proven expertise in team leadership, clinical strategy, and large-scale organizational transformation. Passionate about innovation, problem-solving, and driving high-impact results. Results-driven executive with extensive experience in strategic leadership and operational excellence. Proven track record in driving growth, optimizing processes, and fostering team collaboration. Exceptional skills in strategic planning, financial management, and stakeholder engagement. Adaptable and reliable, consistently achieving high-impact results in dynamic environments.
Overview
21
21
years of professional experience
Work History
VP Global Clinical Operations
Hookipa Pharma
06.2024 - Current
- Build and led a high performing Clinical Operations organization optimizing trial execution cross functionally
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Negotiated high-value contracts that maximized profitability while mitigating risks for the organization.
Head Global Clinical Operations Consultant
Hookipa Pharma
11.2023 - 05.2024
- Collaborated with clients to target issues and uncover methods that would increase operational efficiency.
- Optimized resource allocation by monitoring budgets closely and reallocating resources as needed throughout project lifecycles.
Head Global Medical Affairs
Advanced Accelerator Applications (a Novartis Company)
01.2020 - 12.2023
- Building a strong Global Medical Affairs team while collaboratively working with a strong partner (Novartis)
- Cross-functional execution of the long-range global medical vision on Radioligand therapy (RLT) and Radioligand Imaging (RLI)
- Accountable for review and approval of phase IV trial prioritization and related investment
Chief Scientific Officer (CSO) A.i. Head Clinical Research Germany
Novartis
01.2019 - 12.2019
- Led a 250+ member medical team across 5 franchises, successfully restructuring operations and boosting efficiency
- Plan and supervise clinical trials of Phase IIIb and Phase IV acting as the intellectual driver behind a comprehensive scientific strategy for all trials aimed to integrate, expand and complement data from R&D
- Set the agenda and lead advisory boards, investigator meetings, external medical strategy forums and other key internal and external focus meetings as necessary
- Establishes high-level relationships with global and local key external decision-makers, like FDA and other notified bodies
- Influenced organizational growth strategies by providing expert guidance on emerging scientific opportunities and competitive landscape analysis.
- Led successful grant application efforts, securing vital resources for continued research advancement.
- Managed budgetary planning for departmental resources to ensure optimal allocation of funds towards high-priority projects.
Head Clinical Operations (DACH)
Novartis
07.2012 - 12.2014
- Managing a team of > 300 people including a freelance CRA Model split in 7 indication groups incl
- Resource utilization, hiring new staff, creating budget plans, drafting contingency plans
- Re-org of the organization with the goal of boosting economical and efficient performance while building a collaborative team culture
- Demonstrated strong organizational and time management skills while managing multiple projects.
Group Head Clinical Operation
Novartis
07.2012 - 12.2014
- Responsible for selecting, training, and developing a team comprised of CTAs, CRAs
- Promoting quality and performance standards for clinical trial administration and works to ensure they are documented and understood by the entire team
- Acts as a liaison with other managers in order to assess staff allocation and identify team members available for potential studies
Lead CRA: Arthritis, Neuroscience
Novartis
08.2006 - 09.2009
- Responsible for CRAs performance in up to 10 different trials
- Assesses operational feasibility and preparation of study execution plan
- Responsible for comprehensive study timelines and metrics plus selection and management/oversight of external vendors
- Planning and execution of study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee)
- Ensuring quality standards in reviewing monitoring reports and ensuring resolution of site-related issues
Freelance CRA/Lead CRA
Novartis
03.2004 - 07.2006
- Indications: Rheumatology, Ophthalmology, Bone metabolism, Neuroscience
- Responsible for clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Development of relationships with investigators and site staff
- Responsible for the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
Education
PostDoc -
Martin Luther Unviversity Halle/ Tech. University
Halle, Germany/Munich01-2004
Ph.D. - Regulation of reproductive dominance hierarchies in Apis mellifera capensis workers
University of Halle
Halle An Der Saale10-1998
Staatsexamen Für Lehramt An Gymnasien -
Technical University Berlin
Berlin05-1995
Skills
- Genuine and authentic
- Motivational Mindset
- Fosters Collaborative Trust
- Pragmatic and impact oriented
- Courageous
Board Memberships
- Member of R&D in vfa (pharma association board), 2015, 2021
- Board member of Paul-Martini-Stiftung, 2019, 2021
- Scientific advisory counsel for the ministry of health of Brandenburg, 2018, 2020
- Board member of BaCaTeC (Bavaria California Technology platform for research exchange), 2019, 2023
Telephone
+4915172482664
Leadership Highlights
- Re-organization of the Clinical Operations Team (> 300 people) to mirror business and better fit to needs of the organization plus onboarding of 2 countries (Switzerland and Austria)
- Shaping the Novartis German medical organization (> 250 people) and integrate field medical teams (MSL) into five Therapeutic areas while building new medical support functions (digital; training etc.)
- Building a new Global Medical Affairs Organization for AAA, a Novartis acquired biotech company, through setting up governance structures
- Re-shaping and grow the Clinical Operations Team and apply cross functional collaboration and execute full range of operational activities (Hookipa)
- Diverse portfolio experience of multiple therapeutic areas
Languages
English
Upper intermediate (B2)
Timeline
VP Global Clinical Operations
Hookipa Pharma
06.2024 - Current
Head Global Clinical Operations Consultant
Hookipa Pharma
11.2023 - 05.2024
Head Global Medical Affairs
Advanced Accelerator Applications (a Novartis Company)
01.2020 - 12.2023
Chief Scientific Officer (CSO) A.i. Head Clinical Research Germany
Novartis
01.2019 - 12.2019
Head Clinical Operations (DACH)
Novartis
07.2012 - 12.2014
Group Head Clinical Operation
Novartis
07.2012 - 12.2014
Lead CRA: Arthritis, Neuroscience
Novartis
08.2006 - 09.2009
Freelance CRA/Lead CRA
Novartis
03.2004 - 07.2006
PostDoc -
Martin Luther Unviversity Halle/ Tech. University
Ph.D. - Regulation of reproductive dominance hierarchies in Apis mellifera capensis workers
University of Halle
Staatsexamen Für Lehramt An Gymnasien -
Technical University Berlin
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