The Associate Director, Clinical Supply Chain is responsible for enabling the timely supply of appropriately packaged and labelled clinical trial material for Elevar. This role will work in conjunction with clinical, regulatory, quality, and CMC teams to ensure all ongoing clinical studies are appropriately supplied.
This is a remote-based position located in the United States.Responsibilities:- Develop and implement end-to-end clinical drug supply strategies for global clinical studies
- Working with clinical, forecast investigational product demand based on enrollment, recruitment rates, protocol design, and country-specific requirements
- Develop effective plans while managing risks related to drug demand vs production including working with internal Elevar stakeholders and external partners to manage production, expiry, and inventory
- Work with Interactive Response Technology (IRT) vendors and systems along with relevant stakeholders to manage clinical trial supplies located at manufacturers, depots, and sites while ensuring minimal risk to shortage of supplies
- Contribute to content of the clinical pharmacy manuals, e.g., shipping, storage, and disposal instructions as well as working directly with clinical sites as requested, to dispose of unused/expired clinical supplies
- Manage 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, and assisting with import-export activities
- Represent clinical supply on cross-functional study teams, supporting product and company goals, while managing budget responsibilities and processes related to global clinical supplies
- Manage acquisition, labeling, packaging, shipping, and management of any comparator drugs or other drugs co-administered with Elevar compound(s)
- This role may require working outside normal business hours to ensure service to our global clinical network
Requirements
- Bachelor's degree in an engineering or scientific field with 12 years' experience in clinical supply, including support of late-stage clinical development programs
- Knowledge of cGxP (GMP, GLP, GCP etc.), IRT, and relevant quality systems
- Packaging and label CMO management experience
- Effective communication skills including written, verbal, and presentation skills
- Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
The anticipated annual base salary range for this role is $150,000 to $185,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.
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