Manager, CRO / Laboratory Resources, Clinical Pharmacology

Halozyme Therapeutics   •  

San Diego, CA

8 - 10 years

Posted 223 days ago

This job is no longer available.

POSITION SUMMARY:

The Manager, CRO/Lab Resources will be responsible for CRO management for Clinical Pharmacology department to support Halozyme’s proprietary programs as well as for Halozyme partner programs, namely those supporting current/proposed clinical studies as well as GLP safety assessment studies. 

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

  • Track and obtain critical reagent usage from bioanalytical CRO’s and manage forecasting needs for ongoing and upcoming studies; Use and maintain bioanalytical critical reagent databases
  • Track, maintain, and provide expiry updates to applicable CROs for all Halozyme provided critical reagents
  • Perform tracking/trending analysis of bioanalytical methods and/or stability data
  • Coordinate and monitor transfers of critical reagents and documentation between Halozyme and outsourced labs
  • Source and/or coordinate production of proprietary material/reagents for supplemental validation assessment
  • Develop, execute, and monitor extramural contracts with CROs and/or academic collaborators
  • Manager RFP and contracting processes and coordinate execution of, Legal & Financial documents
  • Provide Finance accrual updates
  • Review operational work plans including requests for proposals (RFPs)/quotes, prepare purchase orders and obtain appropriate legal and financial approvals
  • Ship materials and information required for transfer to and from CROs
  • Receive inventory and manage the inventory management systems for study samples and assay critical reagents
  • Review and edit bioanalytical test methods, protocols and reports
  • Archive Halozyme proprietary reports as well as Halozyme partnered programs
  • Transparently and openly communicate with Halozyme colleagues and extramural collaborators as a team player in a timely manner

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

  • Minimum Bachelor’s degree in Biochemistry or related discipline with at least 7 years’ relevant experience (an equivalent combination of education and experience may be considered)
  • Proven project coordination and management experience with is required
  • Possess an operating knowledge of suitable computer programs, with in depth knowledge of Microsoft Word, Excel, PowerPoint, and relevant database management tools
  • Knowledge of other software highly desirable: Database (e.g., MS Access), MS Project, ReQLogic, Apttus, DocuSign, JMP, Sample Management, Teleconferencing (e.g., Skype Business, Zoom, other)
  • Demonstrate proactive, clear and effective written and verbal communication skills
  • Be well organized and detail–oriented with excellent interpersonal skills
  • Employ effective time management skills and meets deadlines
  • Proven ability to work independently, as well as with a team
  • Demonstrate initiative and resourcefulness as a self-starter
  • CRO, Biotechnology and/or Pharmaceutical industry experiencedesired
  • Understanding of GXP and DOT regulations a plus

R0000363