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Ascentage Pharma · 8 hours ago

Manager Global Clinical Supply Chain

Rockville, MD

Full-time

Onsite

Mid, Senior Level

5+ years exp

Ascentage Pharma is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. The Manager of Global Clinical Supplies is responsible for supporting the global forecasting and planning of investigational materials for clinical studies, ensuring effective supply strategies are executed for clinical trials.

BiopharmaBiotechnologyMedicalPharmaceutical

Hiring Manager

Jason A. Gilmore

Responsibilities

Proactively support the oversight and management of supply strategies for all investigational material based on study needs

Supports the management of investigational products by monitoring and managing clinical supply inventories

Proactively drive the labeling, packaging, release, distribution of clinical supplies for assigned studies, ensuring the project timelines are met or exceeded

Provide support to study teams for distribution queries, IRT support, returns, and destructions

Participate in process improvement initiatives resulting in cohesive supply chain activities

Represent clinical supplies function at clinical trial team meetings and communicate plans and timelines to relevant parties

Foster strong collaboration with all functional partners, including but not limited to Product Development & Production, Supply Chain Management Group, CMC, Clinical Operations, External Vendors, Clinical Medical Management, Regulatory Affairs and others as needed, to assure clinical trials are conducted efficiently and effectively solve abstract problems across functional area of the business

Collaborates with internal GCS teams and external Customers and service providers including but not limited CMC Supply, CMC Product Development, and Regulatory

Ensure appropriate documentation is filed appropriately to the TMF and supports company efforts for inspection readiness

Performs other tasks as assigned

Qualification

Clinical supply chain managementDrug development experienceProject management principlesCGxPsICH requirementsEClinical systems knowledgeMicrosoft Office suiteChange managementCommunication skills

Required

BA/BS in Lifesciences

5+ yrs. Experience in the pharmaceutical industry with at least 3 yrs. experience in drug development, clinical supply chain management, and/or clinical manufacturing or equivalent experience

Experience across multiple functional areas (i.e., clinical, regulatory, quality) demonstrating a broad understanding of pharmaceutical development

In-depth knowledge of all phases of drug development, the functions and processes relevant to drug development, and general project management principles applicable to the biopharmaceutical environment

Experience with planning and execution of investigational materials supply strategies

Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders

Experience managing change in a dynamic, complex environment

Strong background in cGxPs and ICH requirements