Remote work - ideally from East Coast
Really important would be someone that had prepared and gone through an inspection (FDA readiness)
The Senior Manager Clinical Supply is a key contributor to achieve our clinical and corporate goals. The Sr Manager collaborates with stake holders in developing the clinical plans, managing activities to deliver clinical trial supply including budgets to support the drug development process. In this role, you will cooperate with internal and external customers and partners in compliance with regulations, internal procedures and GxP requirements. You are a key leader in delivering complex studies, IVRS and critical functions such as packaging, developing label strategies and defining the logistics strategy for your global trial. This position will closely interface with Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure Clinical material is available as required to achieve clinical trial strategy and timelines. This position interacts directly with clinical sites concerning clinical trial material administered at site or at patient’s homes.
In addition, the Senior Manager will face complex problems related to clinical trial supply and will be required to negotiate on timelines and activities with external and internal entities to ensure supply is available for patients. The Senior Manager will continuously track progress towards objectives and advise management of any issues impacting project timelines and provide solutions to the problems. Responsible for actively managing all Quality Systems related to the Clinical Supply Chain including deviations, investigations, CAPA’s, and Change Control.
- Direct/oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
- Leads the planning, creation and maintenance of IMP supply project plans, based on study forecasts with Clinical and Medical project managers and contract providers.
- Manage Quality Systems required documentation, including on-time open and close of Deviations, Investigations, CAPA’s, Change Controls, Label and Product Specifications, and others as required.
- Evaluate, select, and implement contract manufacturing, packaging, and labeling operations. Negotiate supply/technical agreements, oversee operations, and act as primary liaison between clinical personnel and contractor(s) on assigned projects.
- Identifies process improvement opportunities, recommends pathways for solutions and drives idea generation, proposals and implementation.
- Direct and monitor clinical supply contractor set up, progress and implements corrective actions when issues arise.
- Manages development and implementation of IVRS supply and drug return strategy with contractors and sites.
- Manages Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed.
- Interacts with Clinical sites, caregivers and patients regarding supply needs, storage and return of clinical supplies.
- Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials.
- Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
- Participates as SME for clinical regulatory audits related to supply.
- Represents Clinical Supplies on global clinical project teams
- Minimum of 5 years of related experience in the pharmaceutical industry with at least 3 years of direct experience in Global Clinical Supply Management
- Import/export knowledge desirable.
- Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders.
- Proven ability to select, secure and manage external vendors at a senior manager level to achieve results and control expenditures
- Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double, blind, placebo controlled)
- Thorough knowledge and understanding of cGMP, ICH/cGxP guidelines and global Health Authority requirements.
- Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project.
- Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure.
- Experience with regulatory submissions a plus.
- BS/BA degree with prior clinical supply, hospital or investigational drug service experience