Lead Supply Chain activities for investigational products across multiple phases in clinical development. Collaborate with various teams to ensure compliance with regulations and timelines.
Responsibilities
Lead and manage matrix teams responsible for end-to-end oversight of supply chain activities
Provide consultation on all aspects of investigational product strategies
Design strategies that align with program, protocol, and regulatory requirements
Identify and manage supply chain risk
Manage multi-million clinical supply budgets
Provide guidance and leadership to the Clinical Supply Team (CST)
Oversee activities and identify potential risks
Develop clinical supply solutions including packaging, blinding, and distribution strategies
Act as a point of contact for clinical supply input during audits and regulatory inspections.
Requirements
Bachelor's Degree with 8+ years of demonstrated and relevant experience in pharma/biotech project management and cross functional team leadership
Demonstrated knowledge and experience working in a Good Manufacturing Practices (GMP) (cGMP) and Good Clinical Practices (GCP) (GxP) environment
Demonstrated understanding of pharma quality and regulatory framework
Demonstrated experience leading and delivering in a matrix team environment
Demonstrated electronic, written and verbal communication skills
Demonstrated breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of colleagues to achieve meaningful outcomes and create business impact
Demonstrated understanding of late-stage clinical drug development processes.
Benefits
Limited travel for training or meetings as required
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