Senior Manager, Clinical Trial Supply

Summary

We are seeking a dedicated Senior Manager, Clinical Trial Supply to strengthen our Clinical Trial Supply team and manage a new clinical program, including related clinical trials.

You will work as an individual contributor and partner closely with many functions within the company, e.g. Clinical Operations, Regulatory Affairs and Quality Assurance, joining Immunic at an important time when we are starting a new clinical program. This role combines strong ownership, strategic leadership with hands-on execution.

Responsibilties

Lead Clinical Trial Supply activities for assigned clinical programs and trials throughout the study lifecycle.

Develop and manage Investigational Medicinal Product (IMP) demand forecasts and supply strategies, ensuring compliant and timely supply to investigator sites and trial participants.

Partner closely with CMC and Clinical Operations to forecast and coordinate clinical trial material requirements.

Manage IMP packaging, labeling and distribution activities, including pack design, English master and country-specific labels, and coordination with external vendors.

Develop and maintain key trial supply documentation, including IMP Handling/Pharmacy Manuals and Product Specification Files, and support filing of relevant documents in the TMF.

Oversee IMP distribution, temperature excursions, drug accountability, traceability and destruction in collaboration with external vendors and depots.

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, ensuring alignment across internal and external stakeholders.

Support the development and continuous improvement of Clinical Trial Supply SOPs, processes and documentation.

Qualifications & Experience

Degree in Pharmacy, Pharmaceutical Chemistry, Pharmaceutical Science or equivalent scientific experience.

5+ years of experience, e.g. pharmaceutical or biotechnology experience, including clinical trial research with proven experience leading a clinical program and clinical trials from a clinical trial supply perspective.

Strong knowledge and understanding of global pharmaceutical regulatory requirements (e.g. GMP, GDP and GCP), Eudralex Volume 4 EU guidelines on GMP for investigational medicinal products for human use Annex 13, Clinical Trial Regulation (EU) No 536/2014 Article 63(1), 66-70 and Annex VI.

Excellence in communicating and collaborating (in cross-functional and regulated enviroments), stakeholder management and negotiation skills; ability to operate strategically and hands-on.

Demonstrated experience in Project Management of clinical trial supply activities (phase 1 through phase 3 clinical trials), including product demand/forecast and setup of IRT/RTSM System for a clinical trial.

Fluent communication skills in English.

Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.