Sr. Director – Clinical Supply Management Gene Therapy and Gene Editing

Company:   Eli Lilly

Industry:- Private

Employment Type:-  Full-time

Work Hours:-  8 Hours

Locations:- USA

Full Job Description:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Sr. Director, of Clinical Supply Management is responsible for setting the inventory and cold chain management strategy for clinical products and the supply for clinical trials. The successful candidate will establish strategies and execution plans for labeling, packaging, storage, and third-party logistics of clinical products and supplies.

Duties And Responsibilities

  • Establish the clinical trial and commercial supply chain and cold chain management strategy
  • Establish and maintain supply and demand planning tools for scenario evaluation in cross-functional collaboration, including trackers and dashboards for communication to the broader team to advise and inform manufacturing strategies and decisions
  • Advise on insurance values and coverage in collaboration with stakeholders
  • Establish & maintain process flow maps for the full supply chain
  • Establish and lead Clinical Supply Planning meetings
  • Oversee and manage third-party logistic vendors, effectively communicate expectations, and ensure accountability
  • Work with Clinical, Regulatory, Quality, and Technical Operations to maintain finished drug products (labeled and packaged for clinical use) in support of clinical development programs. Verify that drug products are labeled and packaged according to cGMPs and perform a review of related documentation and the release of finished drug product (labeled clinical trial material)
  • Ensure clinical supplies are delivered to clinical sites on time

Basic Requirements

degree or advanced degree (i.e., Master, PhD ), and 10+ years of experience in the biotechnology, pharmaceutical, or CMO industry, including responsibility for clinical supply management

Additional Preferences

Other Jobs You May Be Interested In

  • Experience with cold chain management for clinical and/or commercial products
  • Experience in gene/cell therapy fields is strongly preferred
  • Shipping Validation experience
  • Supplier/Vendor management experience, including CDMOs and third-party logistic groups
  • General knowledge of drug development for the biotechnology industry
  • Knowledge of cGMP, Quality Assurance, and Quality Control
  • Self-motivated individual with the ability to work independently and as a member of cross-functional teams in a dynamic and highly collaborative environment
  • Well-organized with solid technical, written, and verbal communication skills, as well as computer skills

Sr. Director – Clinical Supply Management Gene Therapy and Gene Editing