Experienced Project Manager and Freelance Consultant in Clinical Drug Development
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- 10178 Berlin
- auf Anfrage
- de | ru | en | fr
- 31.08.2026
- Contract ready
Kurzvorstellung
Geschäftsdaten
Qualifikationen
Projekt‐ & Berufserfahrung
9/2024 – 12/2025
TätigkeitsbeschreibungLed CMC and Supply Chain activities for a critical asset acquisition in the Radiopharmaceutical Field, Orchestrated scale-up technology transfers and established a high-security, global supply chain. Fostered cross-company collaboration to accelerate and enhance the clinical development of the theranostic asset. Setup of manufacturing and distribution network as preparation for product launch in EMA and US.
Eingesetzte QualifikationenSupply Chain Manager, Entrepreneur, Good Manufacturing Practices, Projektplanung
2/2022 – 8/2024
TätigkeitsbeschreibungLed clinical supply operations and managed budget oversight for a strategic in-licensing program within the autoimmune and metabolic therapeutic areas. Drove cross-functional alignment across SCM, Regulatory Affairs, and CMC to execute a seamless, combined Phase 2/3 trial protocol. Mitigated operational and financial risks by agilely adapting manufacturing to a critical, late-stage IMP formulation change.
Eingesetzte QualifikationenSupply-Chain-Management (SCM), Budgetierung, Klinische Arbeiten, Regulatory Affairs, Risikomanagement
8/2019 – 9/2021
TätigkeitsbeschreibungLed cross-functional clinical supply operations for an in-house oncology program, orchestrating the seamless delivery of both IMP and AxMP in close alignment with Clinical Operations and CMC. Orchestrated key stakeholders to develop and implement standardized SOPs, significantly enhancing efficiency and compliance within Clinical Trial Supply (CTS) processes. Developed manufacturing and distribution models for a commercialized drug in US.
Eingesetzte QualifikationenSupply-Chain-Management (SCM), Aufseher, Klinische Arbeiten, Onkologie
11/2014 – 6/2018
TätigkeitsbeschreibungLeading clinical trial supply activities for Biopharmaceutical Drug Development programs (supply budgets over $ 40 M).
Eingesetzte QualifikationenSupply Chain Manager, Aufseher, Budgetierung, Klinische Arbeiten
nicht angegeben
11/2012 – 9/2014
TätigkeitsbeschreibungVerwaltung der Lieferkette für verschiedene globale klinische Studien. Leitung des operativen Teams, das der Forschung zugeordnet ist (über 10 Mitglieder).
Eingesetzte QualifikationenFertigungsplaner, Klinische Forschung
nicht angegeben
11/2011 – 10/2012
TätigkeitsbeschreibungEingesetzte Qualifikationen
Klinische Arbeiten
nicht angegeben
8/2010 – 10/2011
TätigkeitsbeschreibungEingesetzte Qualifikationen
Klinische Arbeiten
Ausbildung
Freie Universität Berlin; Certification by Ministry of Health
Berlin
E.M.A. Universität Greifswald
Greifswald
Über mich
Managing end to end project lifecycle; providing full scale scope, feasibility and risk analyses including financial evaluation, time horizon, capacity and resource planning.
Proven track record of aligning siloed, multifunctional internal and external teams (R&D, CMC, Regulatory, Operations and contracted vendors CMO/CRO) around shared strategic milestones. Adept at breaking down communication barriers to drive cross-functional collaboration and ensure seamless product delivery with precision and high compliance.
Technical expertise: DP/IMP design development, demand forecast & prediction modelling, API/DP/IMP tech-transfer, method & process validation; manufacturing process upscaling, primary & secondary packaging/labeling, import/export, logistics & distribution, IRT integration, contract management; management of TPS (Labs/CROs/C(D)MOs).
Weitere Kenntnisse
Strategic Project Management: Cross-functional leadership, process development & global harmonization, feasibility studies, comprehensive risk assessments, procurement & contract management.
Technical Operations & CMC Strategy: End-to-end CMC and supply chain strategy, API/DP/IMP technology transfers, process validation & manufacturing scale-up, and design development.
Supply Chain & Logistics: Predictive demand forecasting & planning, primary & secondary packaging/labeling, international import/export management, global distribution, import/export, and IRT/IXRS system integration.
Regulatory Compliance: Deep knowledge of ICH guidelines and GxP standards (including cGMP, GCP, GDP); expertise in EMA (EudraLex), FDA (CFR), and German pharmaceutical legislation (AMG).
Vendor & Financial Management: Strategic oversight of Third-Party Suppliers (Labs, CROs, CDMOs), vendor relationship management, and financial evaluation & budget control.
Software & Tools: MS Office, MS Project
Persönliche Daten
- Deutsch (Muttersprache)
- Russisch (Muttersprache)
- Englisch (Fließend)
- Französisch (Grundkenntnisse)
- Europäische Union
- Schweiz
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