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Associate Director Clinical Supply Management

Omega Management Group

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Location: Central NJ, NJ Posted Date: 4/9/2013 Position Type: Full time Job Code: 1046 Required Education: Bachelors Degree

Description

Responsible for organizing and executing all activities involved with the management of investigational products and ancillary supplies in support of a variety of preclinical and clinical study protocols associated with the advancement of all development programs.  In conjunction with information provided by Clinical Operations, develops detailed project plans and timelines to ensure compliant, on-time delivery of the required investigational materials.  Coordinates and manages forecasting, procurement, packaging, labeling, distribution, return, reconciliation, and destruction activities.  Manages inventory levels and distributes monthly inventory and distribution reports.  Tracks the import and customs clearance of labeled supplies being shipped to study sites and depots.  

This individual acts as the primary clinical supply chain contact in working internally with the company product development teams and groups such as Clinical Operations, Manufacturing, Analytical Development/Quality Control, Quality Assurance, and Regulatory Affairs as well as externally with key contract manufacturing, packaging, and logistics suppliers.  


Essential Accountabilities: (Identify the key results produced through listing the primary five to seven duties and responsibilities of the job. List job duties in the order of percent time spent on that accountability.)

            Accountability                  % of Time
1.   Demand Management
Proactively coordinate with internal stakeholders (product development teams and Clinical Operations) to develop a detailed understanding of forecasted global demand for investigational supplies.  Participate in the design of study plans and protocols.  Recommend appropriate blinding strategies along with the type and method of packaging, labeling, and distribution.  Recommend approaches for matching placebo and comparator drug sources.     25
2.   Supply Management
Proactively coordinate internally with Manufacturing group to establish appropriate production plans and timing for bulk drug substance and bulk drug product batches.  Ensure appropriate plans/timing are in place for analytical methods development, formulation and package development, stability studies, and regulatory CMC filings (domestic and international).  Plan and oversee the implementation of expiry date / shelf life extensions.  Coordinate the assessment of temperature excursions during storage, receipt, or transit to study sites or depots.  Coordinate timely material release with Regulatory and Quality Assurance functions.   25
3.   3rd Party Oversight
Proactively coordinate with external 3rd Party service suppliers (e.g., contract manufacturers, packagers, logistics suppliers, etc.) as required to ensure compliant, timely packaging/labeling of investigational supplies.  Design labels to meet customer needs and to ensure compliance with US and international regulations, as appropriate.  Establish appropriate packaging and labeling schedules, including appropriate contingency plans to support unanticipated demand shifts (resulting from enrollment changes, additional sites, etc.) as well as unanticipated supply shortages.  Coordinate the review and approval of all documentation associated with investigational supplies (e.g., label proofs, packaging and labeling specifications and methods, packaging batch records, etc.).  Maintain electronic and paper files associated with investigational supplies.  Manage the performance of 3rd Party service providers to ensure efficient, high quality, cost effective execution of outsourced investigational supply activities.   30
4.   Budgeting and Contract Management
Evaluate, select, implement, and oversee contract manufacturing, packaging, and labeling operations.  Develop associated budgetary forecasts and monitor spending against forecasted activities.  Facilitate the development, negotiation, and approval of formal quotations and proposals; work orders; purchase orders; etc.    10
5.   Compliance, Infrastructure, and Continuous Improvement
Additional responsibilities include the development and optimization of policies and procedures to ensure efficiency while maintaining compliance with relevant global regulations and health authority expectations in regards to investigational supplies.  Proactively identify emerging trends, technologies, and best practices and provide recommendations for implementation as appropriate.  Identify opportunities for improvements related to enhanced compliance, efficiencies, and/or expedited performance.  Support the development of Standard Operating Procedures (SOPs) and guidelines related to investigational supplies (e.g., 3rd Party management, inventory management, distribution, transportation, disposition of returned/unused materials, etc.). Participate as required in internal audits and health authority inspections.   10

6. What is the level of financial responsibility for this job? Please list specific things responsible for.

Departmental responsibilities for cost estimates and budgeting associated with investigational products
and ancillary supplies.  Approval of invoices for items required to support clinical supply chain activities,
including procurement costs, packaging/labeling costs, shipping and distribution costs, etc.

7. What is the management responsibility for this job? Please list specific things responsible for.

Experience working in a multi-cultural environment is necessary with a demonstrated ability to contribute successfully in multi-disciplinary, cross-functional team environment. Must have experience in managing diverse project activities with facilities at different geographical locations.  Will be expected to direct and influence the activities of key internal stakeholders (including those within and outside of the Technical Operations department) as well as 3rd Party service providers.  

8. What is the decision making responsibility for this job? Please list specific things responsible for.

Responsible for forecasting, procurement, packaging, labeling, distribution, return, reconciliation, and destruction activities associated with investigational supplies.

9. What are the working conditions (Office, travel etc…) for this job?

Office working environment with some potential for domestic and international travel expected. (up to 15%) to
meet with CROs and CMOs supporting clinical supply chain activities.    

Requirements

Bachelor’s degree in Pharmacy or a related field (Master’s degree or PharmD a plus). Minimum 10 years of related experience in the pharmaceutical industry with at least 7 years of direct experience in Clinical Supply Management.    
Demonstrated experience with global clinical supply forecasting, planning, manufacturing, packaging, and labeling; inventory management; IVRS systems; production scheduling; importing/exporting; managing 3rd Party service providers (especially for clinical packaging/labeling); and budgetary forecasting/management.  Strong knowledge of cGMPs and GCPs and global Health Authority requirements as related to investigational supplies.  Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.).  
Knowledge of the overall drug development process is considered essential.  Specific knowledge of CMC development activities for biologicals, small molecules, and delivery devices is also desirable including Pharmaceutical Development, Analytical Development, Quality Control, Quality Assurance, and Regulatory Affairs (domestic and international).  As this position resides within the Pharmaceutical Development group within Technical Operations, direct experience with drug product formulation and manufacturing process development is also considered a plus.
Excellent communication skills (both written and oral) are essential as are negotiating, influencing, and project management skills.  
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