QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets.
QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis' proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients.
Summary of Position
QurAlis is seeking a Director, Clinical Supply to join its Global Supply Chain team. The Director, Clinical Supply is responsible for operational oversight of the planning, packaging, labeling and distribution of Clinical Trial Materials (CTM) and any additional study products to support QurAlis clinical trials. He/she is responsible for oversight and management of clinical supply distribution and associated external vendors. He/she ensures operations and activities are executed in accordance with all internal Standard Operating Procedures (SOPs) and in accordance with all country, state, and federal regulations including Good Manufacturing Practice (GMP) regulations and ICH guidelines.
Primary Job Responsibilities:
Partners with Clinical Development Operations to identify demand assumptions, including enrollment rate, number of sites, number of countries, etc.
Schedules and implements labeling, packaging, and quality release operations with CMOs and internally with CMC and Quality departments to ensure continuous clinical supply
Work with Regulatory, QA, Clinical Operations teams and CROs to gather labeling requirements and create, review, and approve Master English Label Text
Work with selected CMOs to generate label proof and label printing to support upcoming labeling runs
Plan and schedule packaging and labeling production runs, review production documents, batch records, specifications, and manage all CMO and internal change control and deviations.
Establish and monitor site and depot level inventory levels, replenish depot and site inventories, manage temperature excursions and proper disposition of products.
Ensures appropriate lead times are planned for the ordering and packaging of clinical trial supplies by monitoring recruitment rates and actual supply needs; ensures continuous re-assessment of supply needs as recruitment and the study progresses by monitoring the use of adequately dated clinical trial supplies at each investigational site
Manages and directs clinical trial supplies return process of vendor by ensuring the reconciliation of CTM and documentation of destruction.
Support selection, design, and implementation of IRT systems, participate in defining user requirements, UAT testing, data integration set up and maintain supply settings for supply management.
Support protocol, IB and pharmacy manual creation, attend and present in investigator meetings as required.
Participates in clinical study team meetings; advises the study team on the optimal supply strategy, aligns with study details and collaborates in achieving study objectives by providing supporting information to the study teams as required; communicates and discusses clinical trial supply timelines, cost and risk limitations
Minimum Qualifications Required:
B.S in a scientific, healthcare, or related field. Pharmacy degree preferred but not required.
10+ years of supply management experience in Pharmaceutical or Biotech industry
Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships, including manufacturing and distribution vendors, CROs, etc.
Experience in IRT systems
In depth knowledge of Pharmacy requirements for clinical trials including applicable regulatory requirements globally
Ability to work independently and as part of the team in a fast-paced environment
Demonstrated ability to juggle multiple competing priorities and demands
Strong attention to detail
Domestic and international travel may be required occasionally