Clinical Drug Supply Manager (m/f)
Date posted: June 12, 2020
Location: Vienna, Austria
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.
We are looking for an experienced Clinical Drug Supply Manager (CSM) with a sound background in pharmaceutical product development to re-design, implement, and optimize HOOKIPA’s clinical supply chain process and ensure global clinical supply for HOOKIPA’s pipeline products.
The position requires excellent communication skills and best-in-class teamwork with internal and external partner.
· Provide strategic direction for clinical supply chain planning activities for HOOKIPA clinical trial studies
· Actively participate 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.
· Provide oversight to CMOs for labeling and packaging, drug depot service, transportation logistics, IMP relabeling coordination.
· Own the clinical demand forecasting, clinical demand planning and clinical inventory planning. Develop 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
· Monitor ongoing study level activity to ensure sufficient supply. Manage inventory targets and safety stock levels.
· 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.
· Manage the logistics of relabeling the IMP with extended expiration date.
· Review and provide input and approval for set up of user requirement specifications for the Interactive Response Technology (IRT) system.
· Support preparation of clinical study manuals/documents such as the pharmacy manual.
· Support Clinical Trial Management, Quality Management, and Technical R&D of in-use stability and compatibility tests as needed for clinical administration of the protocol.
Qualifications & Skills:
· Bachelor’s Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field. MSc/MBA is desirable.
· Excellent communications skills
· 5+ years' experience in production planning and inventory control in the bio/pharmaceutical industry.
· Experience with working with biological safety product(s) 1 and/or 2 is preferred.
· Experience with IMPs that are given as IV administration.
· Strong track record of successfully managing complex supply chains and networks.
· Experience in clinical supply forecasting in complex clinical trials.
· Proficiency with Excel modeling or other supply planning systems.
· 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.
· 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 in Chemistry, Manufacturing and Controls (CMC) fields is a plus.
· Hands-on, solution-oriented personality
· English as a native language or other nationality with top quartile English capabilities (reading and writing)
· International experience
What we offer:
· Strong and highly motivated team
· State of the art infrastructure
· An excellent working atmosphere
· Opportunities for personal development
· Working in a multinational and multicultural environment
We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 3.802,-- based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible
If you (m/f) are interested in this challenging position, please send your CV including cover letter and credentials to: email@example.com
For more information on HOOKIPA please visit www.hookipapharma.com