Associate Director, Clinical Supply Chain

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Requirements:

• 10+ years of experience with a Bachelor’s degree, or 8+ years of experience with a post graduate degree.
• Clinical Supply Chain experience is a must and additional experience in Manufacturing, Quality, and/or regulatory is preferred.
• Strong ability to collaborate and build strategic relationships with internal and external stakeholders (Clinical Operations, Quality, CMC, Regulatory, Contract Manufacturers etc.)
• Comfortable working in a fast-paced, highly matrixed environment.
• Possesses an innovative mindset, with an ability to embrace change, respect differences of opinion, communicate openly and build consensus.
• Demonstrated success in building relationships internally and externally, with highly developed persuasion, influencing, and negotiation skills.
• Thrives in team environments, seeks opportunities for collaboration and value team members success as much as your own.
• Experience working within GxP environments, understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GCP, 21 CFR Part 11, and Annex 13).
• Possess a strong working knowledge of global clinical trials, the drug development process, and supply chain best practices (processes, metrics, systems).
• Expert user in MS Excel and PowerPoint. Strong user of project planning tools such as MS Project and Office Timeline.

Responsibilities:

• Translates clinical trial assumptions into drug forecasts and associated supply/distribution plans, initiates required activities & supply execution processes, and maintains oversight of the production, release, and distribution steps necessary to maintain a continuous supply of drug from FPI through completion of the clinical trial.
• Lead clinical supply chain execution and actively participate and support clinical study teams in all matters related to drug supply as needed to support the portfolio demands for programs progressing toward critical milestones where end to end supply chain execution is required for world class clinical supply delivery.
• Standing member of the CMC and Study Management Teams and acts as a key liaison to the Clinical Operation and Vendor Management teams.
• Is a primary interface to our Clinical Operations customers and is the contact for all strategic clinical supply related issues as it relates to finished goods supplies.
• Participate in the planning, creation and maintenance of IP supply project plans, including creating complex study forecasts with input from Clinical, CMC and Regulatory, as well as contract providers.
• Manage the study budget and ensures accurate and timely payment of invoices to the CMOs.
• Plan and oversee the secondary packaging/labeling and facilitate the process for final drug release.
• Initiates label generation and oversees approvals, label regulatory adaptation and translations activities in collaboration with 3rd party vendors.
• Provides supply-related input and reviews the RTSM URS. Performs UAT and oversees maintenance of the RTSM for supply-related changes.
• Proactive and continuous risk management of the E2E clinical supply chain (back-up countries, inventories, shelf life, etc.).
• Work with Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND/IMPD/CTA filings as required.
• Manage Quality Systems required documentation, including Deviations, Investigations, CAPA’s, Change Controls, Label and Product Specifications, and others as required.
• Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for Trial Master File and Clinical Study Reports.
• Develop and apply Project Plans and Schedules that represent the appropriate level of detail and task independency. Ensure timely follow-up to all commitments in a project plan.