About the Role: Responsible for developing drug supply planning strategy and overall management of supplies for late phase clinical studies. Additionally, for assigned early phase trials, supporting the overall management of assigned clinical studies including project planning, timelines, clinical budgets, resource management, vendor selection/management, and key project deliverables.

Key Responsibilities

• Responsible for developing drug supply planning strategy and overall management of supplies for late phase clinical studies
• Manage clinical supply planning and create drug supply forecast for packaging and labeling operations for study protocols.
• Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy (e.g., location of depots)
• Coordinate the origination, proofing and translation of clinical study labels, as required
• Support design and set-up and provide oversight of specifications for clinical IRT/IVRS system (automated randomization/drug supply management system)
• Oversee a variety of logistics issues, including but are not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing
• Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
• Provide oversight of clinical drug supplies per vendor oversight plans
• Coordinate and manage drug supply vendors including regular meetings with vendor and clinical operations, ensuring meeting documentation is maintained for the study TMFs, as applicable
• Track clinical supply expiration, and taking into account drug supply forecasts/ enrollment/ inventory levels, ensure new drug manufacturing, packaging, labeling are initiated with adequate time to re-supply clinical study sites as required
• Select and manage vendors, including CRO organizations, according to vendor oversight plans.
• Lead clinical operation activities for assigned clinical projects/program(s) including oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables.
• Daily activities may include updating / reviewing and overseeing study documents and study status, evaluating and keeping in place a suitable resource plan, anticipating and mitigating risks
• Daily activities may include reviewing / contributing to clinical regulatory documents to support upcoming programs (regulatory submissions, clinical overviews, pediatric study plans, etc.

Required Skills and Experience

• Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
• 3+ years of clinical trial logistics and / or drug supply experience with late phase trials.
• 5+ years of clinical trial experience in capacities of coordinating and managing operational activities.
• Knowledge of international regulatory requirements (FDA, EMA, GCP, GMP, GDPR).
• Experience in and knowledge of the pharmaceutical development process

Preferred Qualifications

• Broad understanding of regulatory GMP requirements for IMP product packaging and supply
• Excellent organizational and leadership skills.
• Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments