Manager, IMP Supply (Clinical Trial Supply Management)
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Manager, Investigational Medicinal Product Supply / Clinical Trial Supply Management
- End-to-end supply of global Phase I-III clinical trials with study medication from Drug Product manufacture to on-site disposal in accordance with GxP requirements.
- Accountable for management, coordination and efficient on-time delivery of study medication (IMP= Investigational medicinal product, Non-IMPs, Placebos, Standard of Care and disposables) supply for global Phase I-III clinical trials to enable the fulfillment of company milestones (FPD=first patient dosed). This includes demand forecasting, resupply planning, label design, packaging, distribution, destruction, drug accountability and active contribution to clinical core documents (Clinical Trial Protocol, Pharmacy Manual, Site Selection Questionnaire, etc.).
- Collaborate to develop strategic global plans with Regulatory Affairs, Clinical Development, Clinical Operations and CMC professionals to ensure optimal drug supply, considering availability of drugs, expiry dating, production slots, import and export requirements and patient activity for all sites in clinical trials/Program and in line with changing (updated) needs. Responsible for consolidation and communication of the revisions to internal and external partners (BNT entities, CMO).
- For studies using IRT (Interactive Response Technology) support the development and implementation of specification(s) and UAT for IMP supply (medication management) module and maintenance after Go live of the system.
- Ensures compliance with SOPs, GMP, GDP and GCP regulations of activities and documentation for clinical trial supply.
- Ensures consistency and compliance across all studies within R&D Program/allocated clinical trials.
- Accountable for implementation and execution of deviations, changes and CAPAs.
- Participates in and supports internal/external inspections and audits.
- Supports development of standard operating procedures and contribute ideas to improve the performance and quality of the clinical trial supply processes.
- Accountable to perform IMP-related risk assessments for allocated clinical trials (R&D Program) and to ensure traceability of all trial-related medication over the duration of the clinical trial.
- Assists in or leads risk evaluation processes and the conduction of complaint or recall events to ensure patient safety.
- Initiation, set-up and conclusion of supply contracts (Quality Assurance Agreements, Master Service Agreements, Scope of Work, Work orders, etc.).
- Oversee external costs for budgeting purposes for study medication, external CMO packaging/labelling/distribution services and manage respective inventories as required in collaboration with CTS Vendor Management.
- Responsible for vendor surveillance & performance management, on-time completion of outsourced tasks/activities for allocated global clinical trials Phase I to III.
- Performing risk assessments, lessons learned sessions, continuous improvement of processes.
- Representing Clinical Trial Supply Management in internal and external project and trial teams.
- Involvement in recruiting, coaching and training of less experienced team members to acquire all theoretical and practical knowledge to guarantee functional management of the Clinical Trial Supply Management activities (no line management).
- Demonstration and promotion of the company vision and values.
- Adherence to the regulatory requirements and the respective procedures (policies, SOPs, instructions)
What you have to offer.
- Degree in pharmacy, chemistry, biotechnology, biochemistry or related discipline or engineer with profound understanding of natural scientific processes
- Clinical Project Management experience in pharmaceutical or biotech industry
- Knowledge and experience in relevant legislation and international GMP, GDP and GCP guidelines
- Proven track record of supply chain and logistics set up and management in clinical trials up to Phase II/III
- Basic knowledge in implementation and maintenance of IRT systems / EDC systems / ERP systems and other applicable electronic CTSM systems
- Proven track record in supply chain management, labelling requirements in life science industry and in writing of quality relevant documents, e.g. SOPs, deviations, change controls
- Business-professional English language skills
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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