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Job Description
Department:
Job Title:
Reports to:
Global Supply Chain and Logistics
Senior Director Global Supply Chain and Logistics
Chief Executive Officer
Primary Objective of Position
The Senior Director, Global Supply Chain & Logistics shall be responsible for the leadership and
management of global supply chain activities in support of Puma Biotechnology, Inc. clinical development
programs and registration of Puma drug candidates. This position will oversee contract manufacturing
operations related to packaging, labeling and distribution operations, and inventory and distribution drug
supporting all of Puma Biotechnology, Inc. (Puma) drug candidates through the oversight management
of multiple Contract Manufacturing Organizations (CMO's), and related distribution providers.
Major Duties/Responsibilities
This individual will be responsible for developing business processes supporting global supply chain
activities for both a clinical aspect and for a commercial organization while maintaining compliance to all
applicable requirements and meeting Puma overall objectives.
1.
2.
3.
4.
Lead Supply Chain group in developing and executing supply to patient strategies including:
a. Planning and forecasting,
b. Packaging and labeling operations
c. Order fulfillment
d. Management of global distribution networks and development of logistic strategies
Collaborate to develop Strategic Global plans with Regulatory Affairs, Quality and Clinical
Operations counterparts to ensure supply strategies align with company’s expectations and
applicable regulations.
Manage the storage, distribution and inventory tracking of inventory through the supply chain in
accordance to relevant regulations. Develop tracking systems documenting lot usage per clinical trial.
Meet financial objectives of Puma by developing and maintaining accurate budget projections.
5.
Manage vendor selection related to packaging, labeling and distribution, comparator sourcing and any
others as required. Work with stakeholders as required in selection/qualification of CMO’s and to
negotiate effective supply and technical agreements.
6.
Build and maintain effective business relationships with Puma’s Supply Chain vendor portfolio,
ensuring Puma’s objectives are being met based on quality, cost and performance.
7.
Leads development of Standard Operating Procedures (SOP’s) as required. Ensure department
compliance with Puma’s internal procedures and all relevant requirements.
Build, lead and manage an effective supply chain organization. Develop staff by coaching and
mentoring.
8.
Skills & Abilities
-
Project Management skills in multidisciplinary environment
Problem solving ability–develops and executes complex strategies spanning global regions, analyze
and resolve complex logistical issues in compliance with regulatory and quality requirements.
Excellent Organization skills, ability to quickly adapt and react to changing environment.
Lead multidisciplinary teams with excellent oral and written communication skills.
Motivated and self-directed
Strong knowledge of cGMP’s, ICH and CGXP’s
Strong vendor management skills, including contract negotiation and legal review terms.
Excellent business partner with ability to support, develop and maintain effective internal and
external relationships.
Financially savvy, with experience in preparing budgets and on inventory financial management.
People development skills
Strong influencing skills.
Physical Demands
The physical demands described are representative of those that must be met by an employee to
successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and
using office equipment, including a computer, keyboard and mouse, which can cause muscle strain.
While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic
light lifting of supplies and materials may apply. Work is performed in an office environment.
Travel may be required (up to 10%).
Education & Professional Experience
▪
Education
o Minimum Bachelor Degree in scientific, business or health related field. Master’s
degree preferable.
▪
Experience
o Minimum of 15 years in Biotechnology/Pharmaceutical GMP environment with > 5
years of management/supervisory experience. (Manufacturing and/or Supply Chain
experience).