The Clinical Supply Manager has overall responsibility for the provision of clinical material supply for clinical trials and will work closely and collaboratively with their Manufacturing, CMC and Quality and Regulatory colleagues to ensure clinical trial supplies are provided for all clinical trials. This includes ensuring clinical trial supplies are labeled, packaged and distributed according to GXP requirements and trial protocol/enrollment specifications; ensuring clinical supply planning, inventory forecasting labeling, packaging and distribution is implemented to meet company goals. The Clinical Supply Manager is responsible for scheduling, management and oversight of the clinical trial supply, inventory tracking and acting as the technical lead with the clinical trial supply vendors. Ensures that all activities and operations are in accordance with internal policies and procedures and in accordance with government regulations. This position reports to the Clinical Program Director.
- Collaborate with Clinical Operations, PharmDev, Quality, and Regulatory Affairs to develop strategic plans that will ensure adequate drug supply for all sites in multiple clinical programs. Interprets relevant protocol information to develop packaging/labeling design and/or global distribution strategy. Provides forecast models.
- Work with Adamas’ trial teams and clinical operations to identify and ensure continuous supply of materials. Collaborates with clinical, QA and regulatory on ex-US supply.
- Lead the coordination of activities to meet clinical supply needs, including comparator drugs, IMPD and QP release documents required for conduct of global clinical studies.
- Review vendor proposals; review scope changes; review invoices for accuracy; forecast budget requirements.
- Schedule and manage the labeling, packaging and quality release operations; schedule and coordinate activities with the Adamas team to ensure ongoing supply for each clinical study.
- Collaborate with Clinical Operations in developing user requirements for new IXRS builds.
- Responsible for identifying, managing and providing necessary documents such as import licenses/permits needed for global clinical trials.
- Develop tracking systems to document the genealogy and lot usage history during clinical trials.
- Manage the storage, distribution and tracking of the labeled and packaged inventory at the vendors/depots. Manage the multiple vendor relationships required to maintain the day-to-day fulfillment of drug shipment requests.
- Manage the completion of investigations and CAPAs from excursions or deviations that may occur during shipment, handling or storage through collaboration with the applicable team members such as Quality, Clinical and applicable vendors.
- Manage the returns/destruction and reconciliation of clinical product at the appropriate time in the study. Collaborate with Clinical Operations and the vendors to accomplish in a cost effective and compliant manner.
- Collaborate with Regulatory, Clinical Operations, QA and the Label Vendor/CMO to develop the label specifications for primary and secondary packaging, as applicable.
- Summarizes discussions, agreements and decisions made during various meetings for both Adamas and its partners. Serves as a facilitator during these meetings when needed in order to maintain timelines and facilitate resolutions.
- Keeps track of project progress through closely following project plans and Gantt charts.
- Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations
- Minimum of 7 years of project management experience working with Clinical Supplies/Supply Chain and logistics in a Biopharmaceutical, Pharmaceutical or CRO/CMO. Minimum of 2 years-experience managing vendors.
- Project management
- Complex logistics
- Clinical forecasting and budgeting
- Managing suppliers effectively
- Good communicator and collaborative style
- Experience in clinical supply packaging and labeling and knowledge of global clinical supply chain is a plus
- Adequate knowledge of intellectual property considerations, rational drug design and familiarity with regulatory expectations from major geographic regions such US, EU.
- Good interpersonal and follow-up skills
- Skilled in Microsoft Excel, Microsoft Project and Gantt charts
- Ability to travel up to 15%
- Successful experience in a fast-pace entrepreneurial environment;
- Fit with Adamas culture and values
To apply for this position please send your resume to firstname.lastname@example.org with the job title in the subject line. Principals only, no recruiters please.