Associate Director, Clinical Supply Chain
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Job Description
Associate Director managing clinical drug supply strategies, packaging, labeling, and shipments for Elevar Therapeutics’ global biotech trials. Ensuring timely, compliant supply across clinical sites.
Responsibilities:
- Develop and implement end-to-end clinical drug supply strategies for global clinical studies
- Forecast investigational product demand based on enrollment, recruitment rates, protocol design, and country-specific requirements
- Develop plans and manage risks related to drug demand versus production
- Coordinate with internal Elevar stakeholders and external partners to manage production, expiry, and inventory
- Work with IRT vendors and systems to manage clinical trial supplies at manufacturers, depots, and sites
- Contribute to clinical pharmacy manuals, including shipping, storage, and disposal instructions
- Work with clinical sites to dispose of unused or expired clinical supplies
- Manage drug shipment requests, track shipments, resolve shipment issues, and respond to clinical site drug-supply questions
- Assist with import-export activities
- Represent clinical supply on cross-functional study teams
- Manage budget responsibilities and processes related to global clinical supplies
- Manage acquisition, labeling, packaging, shipping, and management of comparator drugs or co-administered drugs
Requirements:
- Bachelor’s degree in an engineering or scientific field
- 12 years’ experience in clinical supply, including support of late-stage clinical development programs
- Knowledge of cGxP (GMP, GLP, GCP etc.)
- Knowledge of Interactive Response Technology (IRT)
- Knowledge of relevant quality systems
- Packaging and label CMO management experience
- Effective written, verbal, and presentation skills
- Ability to collaborate effectively while working remotely
- Willingness to work outside normal business hours as needed for the global clinical network
Benefits:
- Medical insurance
- Dental insurance
- Vision insurance
- Time off
- Retirement plan
- Other voluntary benefits
- Competitive wages
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