PositionThe Associate Director, Clinical Supply Chain manages investigational medicinal product supplies for the trials in EikonTx's global clinical-stage portfolio. This involves translating clinical study information into a demand plan, managing clinical trial supply at CMOs/depots/sites, and maintaining essential documents. This Clinical Supply Chain leader also serves as the primary supply chain lead on Study Management and CMC Teams for assigned clinical programs.
About YouYou have demonstrated experience in performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain responsibilities and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). You work well cross-culturally and cross-functionally with both internal and external stakeholders. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise. You have excellent communication and organizational skills.
What You'll Do- 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.
- Standing member of the CMC and Study Management Teams and act as a key liaison to the Clinical Operations and Vendor Management teams.
- Serve as a primary interface to our Clinical Operations customers and 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 translation 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 risk 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, CAPAs, 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 interdependency. Ensure timely follow-up to all commitments in a project plan.
Qualifications- 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 values team members' success as much as their own.
- Experience working within GxP environments; understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GCP, 21 CFR Part 11, and Annex 13).
- Possesses 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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 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
The expected salary range for this role is $170,000 to $204,750 depending on skills, competency, and the market demand for your expertise.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
