Manager, Clinical Supplies

Employer
Astex Pharmaceuticals
Location
94588, Pleasanton
Posted
Nov 28, 2018
Required Education
Bachelors Degree
Position Type
Full time

Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html

The Manager, Clinical Supplies supports the Clinical Supplies team’s activities related to Clinical Trial Material (Phase 1-4), cooperates with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements. Responsible for managing complex studies requiring Clinical Supplies project management, forecasting, IXRS, distribution, and supply logistics such as packaging/labeling and global distribution. This position interfaces with Clinical, Project, QA, and CMC teams. This role reports to the Director, Clinical Supplies.

Responsibilities:

• Develop clinical supply chain strategies and implement the planning, creation and maintenance of Investigational Medicinal Product (IMP) based on study and drug forecasts with Clinical and Medical project managers

• Accountable for the scheduling and timely delivery of packaged IMP including randomization, packaging, labeling, and global distribution of clinical supplies

• Manage/execute labeling and packaging operations with vendors. Works with Director, Clinical Supplies or designee to negotiate supply/technical agreements.  Acts as primary liaison between clinical personnel and contractor(s) on assigned projects for day-to-day operations

• Provide leadership with IXRS vendor selection in partnership with Clinical Operations and BDM. Support the development and implementation of IXRS supply and drug return strategy with contractors and sites.

• Maintain Clinical Supplies inventory for assigned projects by interfacing with vendor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed

• Assist with developing Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, and disposition of returned/unused materials

• Ensure that key supply project milestones are met while maintaining open communication on supply plan timelines with internal and external customers and partners

• Proactively drive cross-functional activities working with internal and external line functions

• Accountable for budget management for assigned programs

• May mentor junior staff to improve departmental capabilities

Qualifications:

• Minimum BA/BS degree plus 4 years’ experience handling clinical supplies within the pharmaceutical industry 

• Demonstrated ability to handle clinical supply chain management, maintain customer relations, multi-task, and negotiate and meet critical timelines 

• Oncology Clinical Supplies experience a plus

• Strong forecasting/projections skill set for determining required IMP

• Excellent project management skills

• Excellent oral and written communication with the team, peers, management, and external contacts

• Excellent planning, organizational, analytical, and management skills

• Strong attention to detail

• Proven decision-making and negotiation skills experience

• Proficient with interpreting cGCPs, cGDPs, regulations and ANNEX 13 guidelines

• Proficient with personal computers and Microsoft Office Products including Word, Project, Power Point, and Excel