Manager, Clinical Drug Supply
- Employer
- Pharmacyclics, LLC
- Location
- Sunnyvale, CA, United States
- Start date
- Jan 11, 2019
View more
- Discipline
- Clinical, Clinical Research, Science/R&D, Pharmacology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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 available drug supply for ongoing studies:
- Label coordination with CMOs
- Distribution timeline and coordination of product shipment with vendors and PCYC Logistics
- Batch Record Review and coordination of QP release
- Manage temperature excursions to resolution
- Manage supply inventory for global studies:
- Control site supply in partnership with the Clinical Operations team to address any supply issues thereby ensuring no interruptions to the progress of studies
- Manage IP distribution settings in IRT to ensure adequate and timely supply to clinical sites.
- Solicit, review, and manage CMO quotations and work orders / initiate purchase orders for work to be completed / review and approve vendor invoices
- Manage the demand forecasting as part of the planning cycle and lead communication with CMO:
- Review updates received from Clinical Operations and translate into demand forecasting. Manage active enrollment data for ongoing studies per IRT and update demand forecasts
- Adjust supply plans for ongoing studies per defined guidelines
- Lead the management and supply requirements discussion with assigned CMO and at Clinical Study Team (SMT) meetings.
Qualifications:
- Minimum of 5 years' experience in Pharmaceutical GMP clinical supply chain, Operations
- 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 and IRT systems
Education Requirements (degree, certifications, etc.):
Bachelor's degree in biological sciences
#LI-SH40
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Company
Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immunemediated diseases. Pharmacyclics’ mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com.
- Website
- http://www.pharmacyclics.com/
- Mini-site
- Pharmacyclics, LLC
- Phone
- 408-774-0330
- Location
-
995 East Arques Avenue
Sunnyvale
California
94086
US
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