2385255 CatalYm GmbH Program Management & CMC Vollzeit (Senior) Clinical Trial Supply Manager (f/m/d) Your mission

Key Responsibilities

  • Clinical Supply Execution
    • Translate study requirements into operational supply and distribution plans.
    • Manage demand and supply planning to ensure continuous and compliant IMP availability.
    • Oversee packaging, labeling, QP release, distribution, and returns/destruction activities.
    • Act as IRT system owner for supply chain (study setup, shipments, drug assignment, etc.).
  • Vendor & CDMO Management
    • Lead day-to-day CDMO project coordination, including regular calls and timeline tracking.
    • Monitor packaging/labeling progress, batch documentation, release, and distribution.
    • Manage distribution plans, logistics schedules, and timely issue resolution.
    • Define, implement, and maintain SOPs and compliant processes.
    • Drive vendor performance through structured governance and proactive communication.
  • Logistics & Distribution
    • Coordinate IMP, QC/stability sample, and DS-DP transfers and imports worldwide.
    • Serve as point of contact for clinical-site shipment queries and troubleshooting.
    • Define, implement, and maintain logistics SOPs and compliant processes.
    • Ensure adherence to GDP and import/export requirements.
  • Governance & Cross-Functional Collaboration
    • Represent Supply in study, program, and vendor governance meetings.
    • Align closely with TechOps, Clinical Operations, Regulatory, QA, and Finance on study readiness and execution.
    • Track and report key supply metrics; identify and drive process improvements.
  • Administrative & Other Duties
    • Manage storage and transport insurance coverage.
    • Review, approve, and track supplier invoices; ensure budget adherence.
    • Contribute to continuous improvement initiatives and support evolving priorities.

]]> Your profile
  • Bachelor’s or Master’s degree in Supply Chain, Logistics, Life Sciences, or related discipline.
  • 8 – 12 years’ experience in clinical trial supply management, ideally in oncology or biologics.
  • Proven experience managing CDMOs and logistics vendors (packaging, labeling, distribution).
  • Strong knowledge of GxP, GDP, IRT, QP release, import/export, and cold-chain operations.
  • Strong project-management, problem-solving, and stakeholder-communication skills.
  • Hands-on, execution-focused mindset; comfortable working autonomously in a fast-paced biotech environment.
  • Fluent in English (German a plus); occasional travel to vendors or partners.
    • ]]>     Why us?
  • Contribute directly to the success of cutting-edge oncology programs.
  • Be part of an agile, collaborative biotech environment with visible impact.
  • Enjoy flexibility, ownership, and professional growth within a supportive culture.
    • ]]>     permanent experienced full-time 7-10 general_and_other_medical_and_health medical_and_health 2025-10-14T13:00:41+00:00     2526854 CatalYm GmbH Drug Safety Vollzeit Senior Safety Physician Your mission In this role you will lead the strategic direction for Clinical Drug Safety, overseeing the evaluation of the safety profile of our products throughout their lifecycle. You will also shape and implement safety standards and drive the overall safety strategy supporting our clinical development programs.
    Responsibilities:
    • Provide medical expertise and judgement in safety surveillance activities including periodic safety reports, safety signal detection, and in creation and updates of development risk management plans.
    • Evaluate and manage risks associated with assigned projects and make recommendations for the management communication of risks, in accordance with global legal and regulatory frameworks.
    • Lead the Signal Detection process for the CatalYm projects
    • Provide Safety medical expertise and judgement in the production of high quality and timely Safety documents such as DSURs, Safety Summaries and Overviews for regulatory submissions.
    • Perform the medical review of serious adverse event reports, including sponsor causality and expectedness assessment
    • Implement and oversee the execution of Safety Data Exchange Agreements in projects where CatalYm is partnering in clinical development 
    • Provide medical Safety expertise to ensure high quality and timely responses to safety queries from all sources, including Regulatory Authorities.
    • Provide medical expertise and judgement to Project Teams with respect to safety aspects of the design and preparation of trial protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical trial data and lead the safety analyses of the assigned projects.
    • Provide medical Safety input during development of relevant SOPs, working instructions, and guidelines. Owner of the CatalYm Safety System within the overall Quality Management System

    ]]>     Your profile
  • MD with several years of practical experience in patient care.
  • More than 5 years of experience in clinical Safety with global trials in the pharmaceutical industry (preferably including biologics)
  • Familiar with Safety relevant ICH Guidelines and ICHE6(R3)
  • Familiar with EU and FDA Safety reporting requirements
  • Fluent in English (writing and speaking)
  • Based in Munich area with ca. 2 days per week in the office
    • ]]>     Why us?
  • Contribute directly to the success of cutting-edge oncology programs.
  • Be part of an agile, collaborative biotech environment with visible impact.
  • Enjoy flexibility, ownership, and professional growth within a supportive culture.
    • ]]>     permanent experienced full-or-part-time 5-7 clinical_research r_and_d_and_science 2026-02-11T15:40:23+00:00