The Senior Manager of Supply Chain at Scholar Rock has the responsibility of managing the supply of investigational product(s) (IP) for early and late-stage clinical trials as well as aid in commercial supply chain activities. This involves creating supply-demand plans based on the clinical study requirements and outsourcing to external vendors for the labeling, packaging, and distribution of the IP. The primary goal is to meet the clinical demand while ensuring compliance with regulations. This position will work closely with Clinical Operations, Clinical Supply Chain, Quality Assurance, Regulatory Affairs, and third-party CMOs. Strong cross-functional team leadership and project management skills are essential requirements of the role.

Position Responsibilities:

• • Manage packaging, labelling, storage, and distribution vendors.
  • In coordination with Clinical Operations, Clinical Supply Chain, and Technical Operations, develop clinical packaging strategies, timelines, and budgets for existing and upcoming clinical trials.
  • Plan and coordinate Vendor activities for creating label and packaging design(s), scheduling packaging campaigns and production of labels, and coordinating return drug management activities.
  • Facilitate the design, review, and approval of IP label text and label proofs to meet the packaging requirement and compliance with specific country regulations.
  • Collaborate with Clinical Supply Chain to monitor inventory levels at sites and depots closely through the life of a trial, taking preventative actions to avoid any supply issues.
  • Generate and maintain an accurate account of IP inventory on hand including tracking IP consumption, material movements, lot information, and expiry.
  • Working closely with QA, ensure timely review and approval of batch records for packaging and labeling of IP.
  • Collaborate with IRT vendor, distribution vendor, and the clinical study team to develop IRT specifications and perform User testing
  • Manage and follow up on reported Temperature Excursions and/or Product Complaints from sites/depots.
  • Coordinate the expiration date extension and re-labeling operations. Ensure expiry extensions are provided to depot/sites to support continued use.
  • Coordinate the shipping validation shipments and other activity.

Candidate Requirements:

• • Bachelor’s degree or higher in health or life sciences, preferred.
  • Minimum 5 to 10 years of direct experience in clinical supply management from trial start-up to close-out, including planning & forecasting, labeling, packaging, QP release, storage, distribution, reconciliation, returns, and destruction.
  • Experience managing third-party clinical supply vendors required.
  • Experience managing QP releases.
  • Experienced in managing clinical study needs and possesses the skills and ability to support early and late phase Programs.
  • Demonstrated Knowledge of GMP batch record development, review, approval, and release processes.
  • Demonstrated knowledge of warehousing, distribution, and logistics (including cold chain distribution).
  • Strong Microsoft skills, including Excel, power point, etc.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.