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Salary: USD 170,000 - 204,750 / annual
Eikon Therapeutics is a biopharmaceutical company using revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The company's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), featuring microscopes that enable real-time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable protein classes as drug targets.
The Associate Director, Clinical Supply Chain manages investigational medicinal product supplies for trials in Eikon's global clinical-stage portfolio. This role translates clinical study information into demand plans, manages clinical trial supply at CMOs/depots/sites, and maintains essential documentation. The Clinical Supply Chain leader serves as the primary supply chain lead on Study Management and CMC Teams for assigned clinical programs.
Key responsibilities include:
- Translating clinical trial assumptions into drug forecasts and associated supply/distribution plans, initiating required activities and supply execution processes, and maintaining oversight of production, release, and distribution steps to ensure continuous drug supply from FPI through trial completion.
- Leading clinical supply chain execution and actively participating in clinical study teams on all drug supply matters to support portfolio demands for programs progressing toward critical milestones.
- Serving as a standing member of CMC and Study Management Teams and acting as a key liaison to Clinical Operations and Vendor Management teams.
- Serving as primary interface to Clinical Operations customers and contact for all strategic clinical supply-related issues regarding finished goods supplies.
- Participating in planning, creation, and maintenance of IP supply project plans, including creating complex study forecasts with input from Clinical, CMC, Regulatory, and contract providers.
- Managing study budgets and ensuring accurate, timely payment of invoices to CMOs.
- Planning and overseeing secondary packaging/labeling and facilitating final drug release processes.
- Initiating label generation and overseeing approvals, label regulatory adaptation, and translation activities in collaboration with third-party vendors.
- Providing supply-related input and reviewing RTSM URS, performing UAT, and overseeing maintenance of RTSM for supply-related changes.
- Proactively and continuously managing end-to-end clinical supply chain risk (backup countries, inventories, shelf life, etc.).
- Working with Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions and providing support for IND/IMPD/CTA filings.
- Managing Quality Systems required documentation, including Deviations, Investigations, CAPAs, Change Controls, Label and Product Specifications.
- Ensuring appropriate documentation of IP supply activities is provided to clinical trial teams for Trial Master File and Clinical Study Reports.
- Developing and applying Project Plans and Schedules with appropriate detail and task interdependency, ensuring timely follow-up to all commitments.
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; 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.
- Innovative mindset with 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 values team members' success.
- Experience working within GxP environments; understands comprehensive global pharmaceutical regulatory requirements (cGMP, GCP, 21 CFR Part 11, Annex 13).
- Strong working knowledge of global clinical trials, 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.
