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Senior Manager, Clinical Trial Supply
Immunic Therapeutics. Lead Clinical Trial Supply activities for assigned clinical programs and trials throughout the study lifecycle .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Supply Management, including demand forecasting, regulatory compliance, and vendor management. Proven ability to lead clinical programs and trials while ensuring timely and compliant supply of Investigational Medicinal Products.
Highest-signal resume keywords
Clinical Trial Supply ManagementRegulatory Compliance (GMP, GDP, GCP)Demand ForecastingProject Management for Clinical TrialsStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Supply ActivitiesInvestigational Medicinal Product Demand ForecastingIMP Packaging and LabelingTrial Supply Documentation DevelopmentDrug Accountability and TraceabilityClinical Trial Supply SOP DevelopmentIRT/RTSM Systems SetupClinical Program LeadershipTemperature Excursion ManagementContract Negotiation
Soft Skills
Communication SkillsCollaboration SkillsNegotiation SkillsStrategic ThinkingHands-On Approach
Industry Keywords
PharmaceuticalBiotechnologyClinical TrialsEudraLex Volume 4 Annex 13Clinical Trial Regulation (EU) No 536/2014Phase 1 to Phase 3 TrialsTrial Master FileCross-Functional CollaborationRegulated EnvironmentsEU/Germany Work Authorization
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead Clinical Trial Supply activities for assigned clinical programs and trials throughout the study lifecycle
- Develop and manage Investigational Medicinal Product demand forecasts and supply strategies
- Ensure compliant and timely supply to investigator sites and trial participants
- Partner with CMC and Clinical Operations to forecast and coordinate clinical trial material requirements
- Manage IMP packaging, labeling, and distribution activities
- Coordinate pack design, English master labels, country-specific labels, and external vendors
- Develop and maintain trial supply documentation, including IMP Handling/Pharmacy Manuals and Product Specification Files
- Support filing relevant documents in the Trial Master File
- Oversee IMP distribution, temperature excursions, drug accountability, traceability, and destruction
- Manage external Clinical Trial Supply vendors, including contract negotiations, budgets, forecasts, and invoice oversight
- Represent Clinical Trial Supply in program, study team, and vendor meetings
- Support development and continuous improvement of Clinical Trial Supply SOPs, processes, and documentation
- Work as an individual contributor and partner with Clinical Operations, Regulatory Affairs, Quality Assurance, CMC, and other internal and external stakeholders
Requirements
What you’ll need- Degree in Pharmacy, Pharmaceutical Chemistry, Pharmaceutical Science or equivalent scientific experience
- 5+ years of experience, including pharmaceutical or biotechnology experience and clinical trial research
- Proven experience leading a clinical program and clinical trials from a clinical trial supply perspective
- Strong knowledge of global pharmaceutical regulatory requirements, including GMP, GDP, GCP, EudraLex Volume 4 Annex 13, Clinical Trial Regulation (EU) No 536/2014, Article 63(1), Articles 66–70, and Annex VI
- Excellence in communicating and collaborating in cross-functional and regulated environments
- Stakeholder management and negotiation skills
- Ability to operate strategically and hands-on
- Demonstrated project management experience for clinical trial supply activities in Phase 1 through Phase 3 trials
- Experience with product demand/forecasting and setup of IRT/RTSM systems for clinical trials
- Fluent communication skills in English
- Authorization to work in the EU/Germany is required by the application form
Benefits
Comp & perks- Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace
- No specific benefits, perks, or additional compensation are stated