Jessica Cordes
Clinical Operations | AI Transformation
Experience
Senior Consultant and Trainer
Clinical Excellence GmbH
Global Head of Clinical Operations (Senior Director, Clinical Operations)
Immatics Biotechnologies GmbH
- Drug type: cell and gene therapy (ATMPs) with TCR products and bispecific products
- Overseeing phase I/II clinical trials in solid tumor baskets with T cell products and bispecific products
Head of Clinical Operations
Immatics Biotechnologies GmbH
- Drug type: cell and gene therapy (ATMPs) with TCR products and bispecific products
- Overseeing phase I/II clinical trials in solid tumor baskets with T cell products and bispecific products
- Building a global Clinical Operations department (incl. structure, team, culture and processes)
- Line management and employee development of Clinical Operations resources in Germany and USA, including home-based positions
- Oversight of all Clinical Operations activities and the delivery of company goals
- Global clinical operational input into clinical development plans
- Budget planning and controlling for Clinical Operations
- Implementing an outsourcing strategy for Clinical Operations activities
- Vendor governance
- Implementing Key Performance Indicators and clinical trial scorecard
- Optimizing patient recruitment through a patient engagement program
- Staff recruiting strategy for Clinical Operations
- Selecting vendors (CROs, central labs, and others)
- Implementing a culture of continuous process improvement for Clinical Operations
- Review of current and development of new SOPs (process optimization project)
- Ensuring processes compliant with GCP and ATMP-specific regulations, guidelines, and laws
- QA support during audits
Director, Clinical Operations (Head of Clinical Operations)
Medigene AG
- Drug type: cell and gene therapy (ATMPs), incl. TCR and DC products
- Working on phase I/II clinical trial in Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM)
- Oversight of all Clinical Operations activities
- Line management and employee development of Clinical Operations resources, including home-based positions
- Global clinical operational input into clinical development plans
- Budget planning and controlling for Clinical Operations
- Implementing an outsourcing strategy for Clinical Operations activities
- Vendor governance
- Implementing Key Performance Indicators and CRO scorecard
- Optimizing patient recruitment through a patient engagement program
- Staff recruiting strategy for Clinical Operations
- Selecting vendors (CROs, central labs, and others)
- Implementing a culture of continuous process improvement for Clinical Operations
- Review of current and development of new SOPs (process optimization project)
- Ensuring processes compliant with GCP and ATMP-specific regulations, guidelines, and laws
- Hands-on Clinical Trial Management for Phase I/II clinical trial
- QA support during audits
- Collaboration with the German Association of Pharmaceutical Development Companies
Associate Director, Clinical Development (Clinical Trial Manager)
Medigene AG
- Drug type: cell and gene therapy (ATMPs), incl. TCR and DC products
- Working on phase I/II clinical trial in Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM)
- Responsibility for international clinical trial management (incl. set-up, monitoring, and close-out)
- Clinical trial set-up: feasibility evaluation, protocol discussion, vendor selection, investigator selection, investigator contract negotiations, baseline budgeting, patient insurance, submission to the ethics committee and regulatory authority (PEI), set-up of clinical trial-specific documents and systems
- Clinical trial execution and monitoring: responsibility for consistency with design, implementation, and timelines of clinical trial deliverables; communication and coordination of needed actions and timelines for internal and external functional units; vendor oversight; monitoring of patient recruitment, protocol deviations, and data queries; budget control (incl. accruals); coordination of resources and resolution of conflicts
- Selecting vendors (e.g. CROs, central labs, and others)
- Review of current and development of new SOPs (process optimization project)
- Collaboration with the German Association of Pharmaceutical Development Companies
Senior Manager, Clinical Operations (Clinical Trial Leader)
MorphoSys AG
Manager, Clinical Operations (Clinical Trial Leader)
MorphoSys AG
Clinical Trial Leader
MorphoSys AG
- Drug type: antibodies
- Working on phase I/II clinical trial in Multiple Myeloma and Investigator-Initiated Trial in Chronic Lymphocytic Leukemia (CLL)
- Responsibility for international clinical trial management (incl. set-up, monitoring, and close-out)
- Clinical trial set-up: feasibility evaluation, protocol discussion, vendor selection, investigator selection, investigator contract negotiations, baseline budgeting, patient insurance, submission to the ethics committee and regulatory authority (PEI), set-up of clinical trial-specific documents and systems, IMP demand planning
- Clinical trial execution and monitoring: responsibility for consistency with design, implementation, and timelines of clinical trial deliverables; communication and coordination of needed actions and timelines for internal and external functional units; vendor/CRO oversight; monitoring of patient recruitment, protocol deviations, and data queries; budget control (incl. accruals); coordination of resources and resolution of conflicts
- Line management responsibilities for a team (Clinical Trial Administrators, Clinical Research Associates)
- Review of current and development of new SOPs (process optimization project)
- Due diligence of products with in-licensing potential (project team member)
- Purchase order system implementation (project team member)
- Evaluating benchmarking systems
- QA support during audits
Project Leader
GlaxoSmithKline GmbH & Co.KG
- Drug type: Chemicals
- Working on phase II-IV clinical trials (benign prostate hyperplasia (BPH), gastrointestinal disease, chronic obstructive pulmonary disease (COPD))
- Responsibility for clinical trial management in Germany (incl. clinical trial set-up, monitoring, and close-out)
- Clinical trial set-up: feasibility investigator selection, budgeting, patient insurance, submission to the ethics committee and regulatory authority (BfArM), set-up of clinical trial-specific documents, providing clinical trial training to team members, training at investigator/monitor meetings, supportive actions for patient recruitment (e.g. advertisement)
- Clinical trial execution and monitoring: responsibility for consistency with design, implementation, and timelines of clinical trial deliverables; communication and coordination of needed actions and timelines for internal and external functional units; budget control; coordination of resources and resolution of conflicts
- Clinical trial close-out: coordination of data cleaning, collection of clinical trial documents, communication of clinical trial termination (ethics committee, regulatory authority, investigators)
- Implementation of Lean Six Sigma in ongoing clinical trials
- Review of current and development of new SOPs
- QA support during audits
Project Leader
MDS Pharma Services Central Lab GmbH
- Working on phase II-IV clinical trials (Diabetes, Epilepsy, Dermatology)
- Responsibility for overall clinical trial management (incl. set-up and validation of clinical software database, trial monitoring and close-out, presentation/workshop at investigator, monitor and client meetings)
- Responsibility for consistency with design, implementation, and timelines of clinical trial deliverables based on budget expectations
- Set of clinical trial-specific documents for the Central Lab part
- Communication and coordination of timelines for internal and external functional units
- Coordination of resources and resolution of conflicts
- Participation in the process of new bids and change requests
- Personnel training within the clinical trial team by conducting meetings and providing coaching to team members
- Review of current and development of new SOPs
- QA support during audits
Research Associate
University of Lübeck
- Structural analysis of pathogen-host interactions
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (15.5 years), Biotechnology (11 years), Healthcare (5 years), Professional Services (2.5 years), and Education (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Research and Development (14 years), Quality Assurance (13.5 years), Project Management (12.5 years), Operations (6 years), and Human Resources (2.5 years).
Summary
A Clinical Operations expert with more than 15 years experience in clinical research, including 8 years in hemato-oncology, 6 years in the ATMP area, and 2 years in solid tumors. A self-motivated enthusiast who brings a collaborative spirit into the team and drives company goals and innovation.
Skills
International And Country Clinical Operations Experience
Line Management Experience (On-site And Remote)
Strong Skills In Building The Clinical Operations Department (I.e. Structure, Team, Processes)
Strong Skills In Team Building And Change Management (On-site And Remote)
Training In Ich-gcp, Including Atmp Guidelines
Strong Skills In Project Management And Communication
Training In Lean Sigma (White Belt)
Training In Scrum (Disciplined Agile Scrum Master By Project Management Institute)
Ms Office 365, Incl. Ms Project, Ms Sharepoint, Ms Teams
Purchase Ordering Systems: Sap Cerps, Windows Ax, Business Central
Languages
Education
University of Lübeck
Master of Science, Cell biology and Structural biology · Molecular Life Science · Lübeck, Germany · CPA: 2.0 (good)
University of Lübeck
Bachelor of Science · Molecular Biotechnology · Lübeck, Germany · CPA: 2.6 (satisfactory)
Gymnasium Salzgitter Bad
Secondary School · Salzgitter, Germany
Certifications & licenses
Manager for applied AI Transformation
TÜV Rheinland
Disciplined Agile Scrum Master
Project Management Institute
Lean Sigma White Belt
Profile
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