Senior Manager, Clinical Drug Supply
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary:
- Manage global clinical drug supply activities to ensure investigational product availability for ongoing clinical trials:
- Manage study label coordination with CMOs
- Manage the distribution timeline and coordinate global product shipments in collaboration with transportation vendors and PCYC Logistics
- Track distribution of depot and site supply and reconciliation of returns and product destruction
- Team with preferred vendors for sourcing of comparator products and required documentation to ensure products are received, labeled/packaged and distributed for on-time study starts and per the manufacturing plan
- Perform Batch Record Review and coordinate QP release
Requires 5-10 years experience in Pharmaceutical GMP clinical supply chain, Operations, or program management
- Understanding of cGMP's and pharmaceutical industry procedures and regulations
- Ability to plan, budget and organize.
- Strong, open and transparent communication skills (verbal and written)
- Strong organizational and time management skills
- Strong Project management skills and computer proficiency
- Experience with : MS Excel, Word, MS Project, MS Powerpoint
- Bachelor's degree in biological sciences preferred