Associate Director, Clinical Supply Chain

Summary

Join Eikon Therapeutics as an Associate Director, Clinical Supply Chain, managing investigational medicinal product supplies for global clinical trials. You will translate clinical study information into demand plans, manage clinical trial supply, and maintain essential documents. This leadership role requires collaboration with internal and external stakeholders, strong communication skills, and attention to detail. The position involves managing the supply chain, budgets, and regulatory compliance. Eikon offers a competitive salary, comprehensive benefits, and a dynamic work environment.

Requirements

• Have 10+ years of experience with a Bachelor’s degree, or 8+ years of experience with a post graduate degree
• Have Clinical Supply Chain experience
• Have a strong ability to collaborate and build strategic relationships with internal and external stakeholders (Clinical Operations, Quality, CMC, Regulatory, Contract Manufacturers etc.)
• Be comfortable working in a fast-paced, highly matrixed environment
• Possess an innovative mindset, with an ability to embrace change, respect differences of opinion, communicate openly and build consensus
• Demonstrate success in building relationships internally and externally, with highly developed persuasion, influencing, and negotiation skills
• Thrive in team environments, seek opportunities for collaboration and value team members’ success as much as your own
• Have experience working within GxP environments and understand 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)
• Be an expert user in MS Excel and PowerPoint. Be a strong user of project planning tools such as MS Project and Office Timeline

Responsibilities

• Translate clinical trial assumptions into drug forecasts and associated supply/distribution plans, initiate required activities & supply execution processes, and maintain 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
• Serve as a standing member of the CMC and Study Management Teams and act as a key liaison to the Clinical Operation and Vendor Management teams
• Serve as a primary interface to our Clinical Operations customers and be 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 ensure accurate and timely payment of invoices to the CMOs
• Plan and oversee the secondary packaging/labeling and facilitate the process for final drug release
• Initiate label generation and oversee approvals, label regulatory adaptation and translations activities in collaboration with 3rd party vendors
• Provide supply-related input and review the RTSM URS. Perform UAT and oversee maintenance of the RTSM for supply-related changes
• Proactively and continuously manage risks 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

Preferred Qualifications

Have additional experience in Manufacturing, Quality, and/or regulatory

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site
• Bonus and equity compensation