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Sr. Manager of Clinical Supply

Puma Biotechnology

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Location: Los Angeles, CA Posted Date: 5/6/2013 Position Type: Full time Job Code: Manufacturing Required Education: Bachelors Degree Areas of Expertise Desired: Manufacturing/Production
Oncology
Pharmacology

Description

Primary Objective of Position
The Sr. Manager of Clinical Supplies is responsible for the global supply and distribution of drug products and co-medications for our on-going clinical trials through the oversight management of multiple Contract Manufacturing Organizations (CMO’s) and distribution providers.    



*Must be willing to relocate to Los Angeles, CA. Relocation assistance provided.*

Requirements

Major Duties/Responsibilities

1.   Manage the storage, distribution and inventory tracking of unlabeled bulk product, labeled product, co-medication inventory and Puma Biotechnology’s materials throughout the supply chain at CMO’s in the most cost effective manner and in compliance with cGMP’s.

2.   Manage the day-to-day fulfillment of drug shipment requests for all products under clinical development at Puma Biotechnology in a cost effective and cGMP compliant manner. Manage multiple vendor relationships, supply chain, distributions and return/destruction operations using IVR/IWR.

3.   Collaborate to develop Strategic Global plans with Regulatory Affairs, Quality and Clinical Operations professionals to ensure optimal drug supply, considering expiry dating and patient activity for all sites in a Global Program.

4.   Schedule and implement labeling, packaging and Quality release operations with the CMO and multi-disciplinary team to ensure continuous clinical supply.

5.   Responsible to receive reports on excursions or deviations which may occur during shipment, handling, and storage of drug products. Drive such investigations in collaboration with Quality, CMO and clinical sites to resolution and define and implement procedures to minimize future such occurrences.

6.   Develop tracking systems to document the genealogy and detailed lot usage history of all drugs for each clinical trial.

7.   Working with CMO and CRO’s, manage the distribution and global Depot locations with special considerations on Import Licenses and shipping lead times for country specific requirements.  
Arrange for cost effective return/destruction of all product no longer suitable for clinical use.

8.   Meet financial objectives of Puma Biotechnology by forecasting budget requirements; preparing project budget; reviewing CMO proposals, Issuing and scheduling expenditures; analyzing Change in Scope and reviewing Invoices for accuracy.  




Skills & Abilities

1.   Project Management skills in multidisciplinary environment with complex strategies and geographical specific requirements and ability to adapt to changes.

2.   Excellent organization skills, ability to lead multidisciplinary teams with excellent oral and written communication skills.  

3.   Experienced and successful at Developing Project Budgets, Tracking Budget Expenses, Negotiation, SOX compliance and various financial operations.  

4.   Able to analyze and resolve complex logistical issues in a scientific and heavily regulated GMP environment, considering multiple factors and timelines.  


Education & Professional Experience
1.   Minimum of Bachelor’s degree in scientific or health related field.

2.   Minimum of 6 years’ experience in GMP environment.
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