Manager Clinical Supply Chain, Manufacturing and Supply
Open Position – Manager Clinical Supply Chain, Manufacturing and Supply
This position is responsible for enabling the timely supply of appropriately packaged and labelled clinical trial material for Elevar. The role will work in conjunction with clinical, regulatory, quality, and CMC teams to ensure all ongoing clinical studies are appropriately supplied.
2. Job Details
Work with regulatory to develop drug labels based on the type of study, site location, etc.
Contribute to content of the clinical pharmacy manuals, e.g., shipping, storage, and disposal instructions.
Review and approve drug shipment requests received from clinical operations and/or clinical sites, including:
Tracking shipments to sites.
Management of any issues during shipment.
Responding to any clinical site questions related to drug supply to ensure compliance with appropriate regulatory and quality requirements.
Assisting with import-export activities
Manage clinical trial supplies located at manufacturers, depots, and sites to ensure ample drug supply is always available.
Proactively manage expiration dates for all clinical trials supplies.
Work with clinical sites, as requested, to dispose of unused/expired clinical supplies
Manage acquisition, labeling, packaging, shipping and management of any comparator drugs or other drugs co-administered with Elevar compound(s).
Liaise with clinical to develop clinical use forecasts for manufacturing planning.
This role may require working outside normal business hours to ensure service to our global clinical network.
3. Candidate Requirements
4–8 years of clinical supply chain experience, including support of late stage clinical development programs.
Knowledge of cGXP (GMP, GLP, GCP etc.) and quality systems.
Packaging and label CMO management experience.
Education—Bachelor’s degree in an engineering or scientific field.
Operate with the utmost ethics and discretion, earning trust with peers, team, and entire staff.
Superior communications skills including written, verbal, and presentation skills.