Senior Director of Clinical Supply Chain

Company Description 

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.  Eikon’s clinical development portfolio is poised to expand rapidly.

Position

The Senior Director of Clinical Supply is central to our vision of building an organization that supports a rapidly growing clinical portfolio.  Reporting to the Vice President of Operations, you will have a significant impact on Eikon’s mission.  In your role you will oversee the Global Clinical Supply Chain organization, supporting Phase I, II, III and IV clinical trials.  This role will be an onsite role in New York with flexibility up to 3 days on site.  

About you

You are an exceptional leader.  You have a proven ability to build and lead high performing teams in support of global initiatives.  You work well cross-culturally and cross-functionally with both internal and external stakeholders.

What You’ll Do:

Build and lead Eikon’s Clinical Supply Chain organization, with responsibility to:

• Develop, in collaboration with Clinical Operations, clinical demand and supply plans to ensure accurate and continuous supply to patients in global clinical trials while reducing risk and minimizing waste in support of the clinical team’s trial strategy.
• Collaborate closely with the Clinical Operations organization based in the US on both the West and East Coasts to ensure timely supply of all trials.
• Represent Clinical Supply Chain to senior internal and external stakeholders.
• Work with Eikon’s network of drug Contract Manufacturers to ensure on-time supply.
• Ensure on-time production and distribution across Drug Substance, Drug Product, Packaging and Labeling.
• Manage, in collaboration with Clinical Operations, clinical label development and planning.
• Build strong relationships with senior management (including but not limited to Clinical Operations, Regulatory, CMC, Medical Affairs, and Clinical Development) to ensure alignment of organizations and prompt resolution of critical issues.
• Support the Clinical Demand Review and Clinical Supply Review Processes as part of the Clinical Demand and Operations Planning Process. 
• Support the trial budget estimation process, projecting costs related to IMP and non-IMP drug supply across API, Drug Substance, Drug Product, Packaging, Labeling, Depots and Distribution.  
• Procure IMP and non-IMP drugs globally in support of the defined trial strategy.
• Lead global drug distribution, ensuring trade compliance for both import and export; negotiate contracts to establish local, regional, and global depots.
• Participate in protocol and contract review.
• Support IRT/IXRS testing as needed / requested.
• Support the Clinical Long Range Planning Process.

Qualifications

• Demonstrated track record of leading, inspiring, and mentoring teams.
• A minimum of 15+ years of experience working in the biopharmaceutical industry. Clinical Supply Chain experience is a must and additional experience in Manufacturing, Quality, and/or regulatory is preferred.
• BA/BS in a relevant discipline required. Master’s degree strongly preferred.
• Strong ability to collaborate and build strategic relationships with internal and external stakeholders (Clinical Operations, Quality, CMC, Regulatory, Contract Manufacturers etc.), including senior executives.
• 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.
• You thrive in team environments, seek opportunities for collaboration and value team members success as much as your own.
• You 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)
• Experience working within GCP environments. 
• Possess knowledge and experience leading end-to-end global processes.
• Possess knowledge of global clinical labeling requirements.

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 $213,000 to $245,000, depending on skills, competency and the market demand for your expertise.