The successful candidate will be responsible for ensuring that clinical drug supply is available for global clinical trials, including compliance with international regulatory standards applicable to the storage, transport and labeling. This role includes demand forecasting, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics including import and export management. This position will also be responsible for leading the clinical labeling and packaging strategy for all materials needed for global clinical studies by working closely with internal groups and contracted CROs and CMOs to determine manufacturing and supply needs and timelines. In addition, this position will provide finished goods packaging/labeling support to commercial supply chain activities, as required. The successful candidate will have a background in clinical and commercial supply chain practices as well as a familiarity with the applicable GMP and ICH Quality guidelines, and the ability to incorporate multiple variables into forecasts. Effective communication, collaboration, and planning with team members and other groups will be a critical component of daily activities.
Essential Qualifications and Experience:
* Leads the supply management of all clinical products including demand planning and supply for clinical global studies, management of the labeling and packaging supply chain, and distribution of product to clinical sites.
* Develops strong internal collaboration with stakeholders, including Supply Chain, Clinical Operations, Regulatory Affairs, and Quality to ensure effective cross-functional communication.
* Manages clinical packaging and labeling including label design, translation and production.
* Provides finished goods packaging/labeling support to commercial supply chain activities.
* Creates and manages a supply plan to support the product demand forecast, including determination of supply overage amounts and regular inventory updates to project teams.
* Develops supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
* Manages domestic and international distribution/logistics for clinical programs, including import and export of clinical supplies.
* Establishes and maintains department SOPs, including packaging, labeling, logistics and others, in compliance with internal and regulatory standards and requirements.
* Manages external clinical packaging/distribution vendors, including negotiating third-party contracts, and developing the distribution instructions with clinical supply chain vendors.
* Monitors drug expiration and initiates supply/re-supply to clinical sites, serving as the inventory manager.
* Achieves operational objectives by providing information and recommendations to strategic plans and budget reviews and supporting department budget activities.
* Participates as required in the vetting, evaluation and selection process for clinical inventory systems in conjunction with clinical operations and other cross-functional stakeholders.
* Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained.
Skills & Abilities:
* University degree and a minimum of 6 years' related experience in clinical or commercial global supply chain management or equivalent combination of education and experience.
* Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
* Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment
* Proven experience with forecasting, demand/supply planning, inventory management, clinical, packaging, labeling and distribution including cold chain, and import/export
* Experience in CMO and CRO vendor management
* Working knowledge of the clinical drug development process (Phase I-III)
* Working knowledge of cGMPs and familiarity with US and EU regulations and quality standards
* Strong attention to detail and problem-solving skills, with excellent project management skills
* Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required
* Excellent customer-service orientation, high degree of professionalism, and the ability to work with limited direction
* Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks
* Ability to multi-task and shift priorities quickly while working under tight deadlines
This is a great company to work for and they will offer a competitive base salary, benefits and other perks that will be very appealing. They are looking to hire right away so do not miss out.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 29 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.