Kathleen Richter
Head of Clinical Operations
Potsdam
Summary
Head of Clinical Operations | Clinical Development Leader Clinical Operations executive with 15+ years of experience building and leading global clinical development functions in biotech and CRO environments. Proven ability to design and scale Clinical Operations organizations, deliver Phase I–II programs, and align clinical strategy with regulatory, biomarker, and commercial objectives. Strong track record in funding acquisition (€7.4M), vendor governance, and audit-ready quality systems, with leadership experience as part of senior management teams.
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Overview
2027
2027
years of professional experience
1
1
Certification
Work History
Head of Clinical Operations
4Teen4 Pharmaceuticals GmbH
Hennigsdorf
05.2024 - Current
- Lead end-to-end delivery of Phase I–II clinical programs in critical care and cardiovascular diseases
- Define and implement Clinical Operations strategy, including operating model, KPIs, and governance structures
- Act as key interface to executive leadership, aligning clinical execution with company strategy
- Build and develop a high-performing Clinical Operations team
- Oversee vendor strategy, including CRO selection, contract negotiation, and performance management
- Ensure regulatory compliance and inspection readiness across all studies
- Drive risk-based operational models (RBQM) and continuous process optimization
Head of Clinical Operations
AdrenoMed AG
Hennigsdorf
03.2018 - 05.2024
- Built and led the Clinical Operations function for a venture-backed biotech
- Member of the Senior Leadership Team, reporting directly to the CMO
- Delivered multiple multi-country Phase II trials (septic shock, cardiogenic shock, COVID-19)
- Secured €7.4M in public funding (BMBF) for clinical development programs
- Established audit-ready quality systems, SOPs, and TMF processes
- Defined and implemented vendor governance frameworks
- Integrated biomarker strategies enabling patient stratification and personalized medicine
- Managed departmental budget and resource planning
- Led cross-functional collaboration across RA, CMC, QA, and Commercial
Site Management Lead
Covance Clinical Development Services
03.2015 - 02.2018
- Led regional clinical operations across multiple therapeutic areas
- Managed international teams and ensured delivery of Phase II–III trials
- Implemented risk-based monitoring approaches
CRA → Lead CRA → Project Management
Earlier Career (ICON, Chiltern, Genzyme, CRO Roles)
- Built strong foundation in clinical trial execution and site management
- Managed global Phase I–III trials across multiple indications
Education
Women’s Leadership Program -
Yale School of Management
Skills
- Clinical Operations Strategy & Leadership
- Global Trial Delivery (Phase I–IV)
- Organizational Build-up & Scaling
- Budget Ownership & Resource Allocation
- Vendor Governance & Outsourcing Strategy
- Regulatory Strategy (EU CTR, ICH-GCP)
- Quality Systems & Inspection Readiness
- Biomarker-driven Clinical Development
- Cross-functional Leadership (RA, CMC, PV, DM)
- Teamwork and collaboration
- Problem-solving
- Customer service
- Friendly, positive attitude
- Critical thinking
- Computer skills
- Calm under pressure
- Problem resolution
Accomplishments
- Built Clinical Operations department from scratch to Phase II-ready organization
- Delivered multi-country trials (up to 60 sites, 700+ patients)
- Secured multiple funding for clinical programs
- Recognized for exceptional leadership and performance (per formal reference)
Certification
- Certified Project Manager (CCI)
- Certified Nurse
Languages
English
Advanced (C1)
French
Intermediate (B1)
Timeline
Head of Clinical Operations
4Teen4 Pharmaceuticals GmbH
05.2024 - Current
Head of Clinical Operations
AdrenoMed AG
03.2018 - 05.2024
Site Management Lead
Covance Clinical Development Services
03.2015 - 02.2018
CRA → Lead CRA → Project Management
Earlier Career (ICON, Chiltern, Genzyme, CRO Roles)
Women’s Leadership Program -
Yale School of Management