APICS Hartford County Job Board: Clinical Supply Chain Manager

Date: 2/9/2010
Company: Infinity Pharmaceuticals
Address: 780 Memorial Drvie
City State Zip: Cambridge, MA

Title: Clinical Supply Chain Manager
Openings: 1
Location: Cambridge, MA
StartDate: ASAP
Salary: DOE

Qualifications: Clinical Supply Chain Manager
Location: Cambridge, MA

Infinity Pharmaceuticals, Inc. is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

The Supply Chain Manager will oversee activities related to ensuring drug supply for all on-going and planned world-wide clinical trials (Phase I-IV). This includes management of supply forecasting, labeling, packaging, inventory management and distribution to clinical sites.

Duties: Primary Responsibilities:

Manage drug supply chain operations including forecasting for all clinical trials, working closely and collaboratively with Clinical Trial Managers and the Pharmaceutical Development group.
Ensure that all clinical supplies are controlled and distributed in accordance with GMP, GLP, GCP and GDP regulations.
Direct outsourcing of labeling, packaging and on-time distribution of clinical drug supply to US and world-wide clinical sites.
Work with Clinical Trial Managers, Pharmaceutical Development and Regulatory Affairs to design appropriate labeling, packaging and shipping configurations.
Establish drug supply chain standardization specifications across all clinical trials including the establishment of specifications for blinded clinical trials involving the use of an interactive voice response system (IVRS) and the integration of electronic data capture (EDC).
Establish metrics to define supply chain performance and provide recommendations to optimize operations and build the supply chain function within Infinity.
Represent supply chain function on internal and external cross functional teams.

Experience & Educational Requirements:
A degree in Pharmacy or Natural Science and at least 10 years of experience in drug development and clinical supply chain management.
Experience managing the supply chain for global Phase I to IV studies including knowledge of International packaging regulations, import/export licensure and drug depot utilization.
Advanced knowledge of labeling, packaging, inventory management and distribution procedures related to clinical supplies including experience with intravenous and oral drug packaging designs.
Experience in auditing and managing supply chain and drug packing CMOs.
Extensive knowledge of GMP, GLP, GCP and GDP compliance requirements.
Ability to develop and build a function and proven success with mentoring and training.
Deep understanding of drug development and clinical development processes.
Excellent organizational, planning, communication, negotiation and organization skills.
Basic knowledge of clinical protocol design.
General knowledge of business related areas: project management, contracts, invoicing, and finance.
Working knowledge of relevant IT systems.
Interested Candidates may apply on line at www.infi.com

Contact: www.infi.com
Address: See Above
Phone: 617-555-1212
Fax: 617-555-1212
E-mail: john.rynak@infi.com

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