Senior Clinical Pharmacy Specialist

Description Human Genome Sciences (HGS) is a biopharmaceutical company with approximately 800 employees and world-class R&D and manufacturing facilities based in Rockville, MD. We have three promising products in late-stage development – one, raxibacumab, already commercialized with sales to the U.S, Government and two moving toward commercialization. BENLYSTA™ (formerly LymphoStat-B®) has successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus, and we expect to have results of the second BENLYSTA Phase 3 trial in November 2009. ZALBIN™ (formerly Albuferon®) has completed Phase 3 development in chronic hepatitis C, and we expect the submission of global marketing applications in fall 2009. We are developing both of these products in collaboration with world leaders in the pharmaceutical industry. Further, in July 2009, we secured a new purchase order for 45,000 doses of raxibacumab, a drug to combat inhalational anthrax, to be delivered to the U.S. Strategic National Stockpile over a three-year period. At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow; interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/V Please visit www.hgsi.com for further information on our company and to apply on-line for this position.   HGS' Clinical Pharmacy team is looking for an experienced senior professional who will be responsible for managing staff as well as work closely as a member of clinical project teams including department teams such as Manufacturing, Quality Systems, Regulatory Affairs, Global Project Management, Clinical Research and Clinical Operations.

This seasoned professional will oversee unblinded pharmacy monitoring at HGS clinical sites as needed, present clinical pharmacy related sections at CRO kick-off meetings and investigator meetings.  

The candidate will be the primary clinical pharmacy contact for multiple HGS clinical programs, and coordinate the secondary packaging, labeling and distribution of all HGS clinical supplies.

Other duties include the following:
- Creation and review of pharmacy manuals in accordance with protocols and amendments.
- Create, review and approve monthly clinical supply forecasts for all studies.
- Update SAP as necessary; including input of all clinical shipments, generating packaging ID numbers and “kitting” of clinical trial material
- Develop and maintain clinical pharmacy related working practices and SOPs.
- Monitor clinical supply inventories at HGS contractors.
- Monitor retest dates of HGS products.
- Act as primary liaison between clinical supplies contractor and HGS.
- Coordinate bi-weekly clinical supplies discussion.

Requirements - Minimum of two years experience in clinical supply chain project and people management.
- Excellent people skills are required.
- Knowledge of GXPs, familiarity with ICH and EU regulations.
- Excellent communication and organization skills.
- Good writing and presentation skills.
- Ability to manage multiple tasks simultaneously.