Clinical Trial Drug Supply Manager
|Date posted:||05. August 2022|
We are looking for an experienced Clinical Trial Drug Supply Manager, who defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients. The position requires excellent communication skills and best-in-class teamwork with internal and external partner.
- Provides strategic direction for clinical supply chain planning activities for Hookipa clinical trial studies
- Actively participates in project team meetings to work with cross functional teams including Technical Development, Clinical Operations, Regulatory Affairs, and Quality Management to provide feedback from a clinical supply chain perspective. Identifies potential risks and escalates to the appropriate stakeholders as needed.
- Ownership of contracting CMO for labeling and packaging final drug product, transfer and storage to drug depot, and transportation logistics from drug depot to clinical sites.
- Ownership of all clinical drug supply from the receipt at the initial depot through destruction. Any transfer should be proactively managed, and any issue should be owned and resolved promptly. This includes depot-to-depot shipments and site shipments.
- Owns the clinical demand forecasting, clinical demand planning and clinical inventory planning. Develops the program level demand planning forecasts and budgets based on the book of work for clinical drug supplies through all phases of clinical development for assigned programs. Update the clinical demand based on changes to the study and align between the Clinical Operations and External Manufacturing groups.
- Ability to identify risks of: IMP labeling and packaging; IMP storage at drug depot; transportation to the site; IMP inventory management plan at the site, and transportation to the site; relabeling to extend the expiration date.
- Reviews overall clinical trial protocol/protocol amendments and other related documents (e.g. Pharmacy manuals), provide input to develop efficient packaging design, clinical trial supply design and visit schedule.
- Monitors ongoing study level activity to ensure sufficient supply. Manage inventory targets and safety stock levels.
- Develops, maintains, carries out and optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expire management of clinical supplies
- Acts as the primary liaison for collaborations with Contract Research Organization (CRO) who is supporting the site management and Contract Clinical Supply Depot supporting the labeling and packaging, drug depot, and transportation logistics.
- Manage the logistics of relabeling the IMP with extended expiration date strategy. Ensure the IMP with extended expiration date are provided to depot/sites as needed to support continued use of study drug.
- Develop a labeling strategy that meets regulatory and study requirements. Lead the development and approval of label text and label proofs including country-specific translations.
- Reviews and provides input and approval for set up of user requirement specifications for the Interactive Response Technology (IRT) system. Interacts with the IRT vendor and provide feedback of the clinical trial design to ensure optimal functional use of IRT.
- Support preparation of clinical study manuals/documents including the pharmacy manual, regulatory filings and QP declarations.
- Support Clinical Trial Management, Quality Management, and Techinical R&D (TRD) of in-use stability and compatibility tests as needed for clinical administration of the protocol.
- Maintain required documentation related to study drug and supply chain activities in the Trial Master File.
- 3+ years' experience in clinical trial drug supply management at bio/pharmaceutical industry or CRO.
- Experience with IMPs that are biologics and given as IV formulation.
- Bachelor’s Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field. MSc/MBA is desirable.
- Experience in clinical forecasting including the ability to translate complex clinical trial designs into demand forecasts and supply plans to meet business objectives
- General knowledge of Interactive Response Technology (IRT) system.
- Experience in clinical packaging and labelling, drug depot warehousing, & IMP transportation/distribution.
- Excellent communications skills
- Proficiency with Excel modeling or other supply planning systems.
- Strong social skills
- General knowledge of current GMP/GCP/GDP regulations.
- Experience in a highly matrix environment with demonstrated leadership. Collaborative team player with strong interpersonal skills and ability to drive team actions and results.
- Any formal project management training and experience is highly preferred
- Highly organized and efficient, able to orchestrate multiple projects simultaneously and willing to accept responsibilities outside of current role.
- Strong quantitative and analytical skills with excellent attention to detail.
- Self-motivated, thrives in a fast-paced, small company environment with minimal direction and able to adjust based upon changing priorities.
- Experience with drafting a pharmacy manual for IMP preparation and administration.
- Experience in CMC fields is a plus.
- Hands-on, solution oriented personality
- English as a native language or other nationality with top quartile English capabilities
- International experience
- Valid working permit
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
- Currently it is a remote position. There may be requirements to be at the HOOKIPA office in New York City, NY upon request.
We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible