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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 1090720

(Pre) Clinical Drug Development

  • Pharma & Biotech
  • Asap
  • Immunogenicity & Immunology, Cell-based Assays
  • K-Recruiting Schweiz AG
Ansprechpartner:

Julius Strack

+49 89 1890998-21

julius.strack@k-recruiting.com

Overview

Availability
Asap; full-time; remote & on-site
Qualification
PhD in Immunology
Language Skills
English (business fluent), German (fluent), Dutch (fluent)
Relevant Expertise
(Pre) Clinical Drug Development, Immunogenicity, Immunology, Bioanalysis, ADA Assays (LBA), Cell-based Assays, Translational Development, Preclinical Development, Regulatory Strategy (FDA/EMA), GMP/GLP/GCP, CRO/CMO Management

Key-Facts

  • Internationally recognized immunology, immunogenicity and bioanalytical expert with 15+ years across biologics, vaccines, gene & cell therapies and advanced drug delivery, spanning preclinical to clinical readiness

  • Proven leader in preclinical-to-clinical translation, defining tox, PK, proof-of-concept, biomarker and immunogenicity strategies, with deep hands-on expertise in LBA and cellbased ADA assays

  • Highly experienced in regulatory strategy and direct FDA/EMA engagement, guiding programs through IND/clinical readiness while ensuring alignment with GMP/GLP/GCP and robust potency and release approaches

  • Trusted advisor and board-level contributor managing CRO/CMO/vendor ecosystems, leading due diligence and innovation evaluations, and delivering executive-level training consistently rated among top lecturers

Extract from Previous Activities

2 0 2 3 – D a t e

Associate Partner

  • Lead and advise on preclinical, translational, and bioanalytical strategies

  • Support client programs from early development through clinical readiness

  • Complement commercial teams with deep scientific and regulatory expertise

2 0 1 6 – D a t e

External Evaluator

  • Evaluate and rate innovative business plans in next-generation biologicals

  • Contributed to successful seed funding decisions for early-stage biotech companies

2 0 1 2 – D a t e

Consultant Trainer

  • Deliver global training courses in biopharmaceutical development

  • Consistently ranked among top lecturers based on participant numbers and evaluations

2 0 1 8 – 2 0 2 5

Interim Director of Biology

  • Led mode-of-action studies for a silica nanoparticle nucleic-acid delivery platform

  • Provided scientific leadership supporting first-in-human readiness

2 0 1 7 – 2 0 2 4

Interim Director of Vaccines

  • Led manufacturing and regulatory approval strategy for plasmid-based vaccine candidates

  • Guided development of disruptive vaccine technologies for livestock

2 0 1 8 – 2 0 2 3

Subject Matter Expert, Bioanalysis

  • Defined clinical bioanalytical and immunogenicity strategies

  • Led immunogenicity risk assessments and vendor oversight

  • Supported development of a novel monoclonal antibody

2 0 1 7 – 2 0 2 0

External Expert

  • Resolved regulatory and bioanalytical challenges for multiple clients

  • Supported transition from late preclinical to first-in-human across drug classes

2 0 1 4 – 2 0 1 6

Interim Head of R&D & Preclinical Development

  • Built and led R&D teams

  • Drove proof-of-concept studies and IND preparation

  • Managed CRO/CMO outsourcing and innovation risk strategy

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