Manager, Supply Chain Lead (SCL)

As a Manager, Supply Chain Lead, (SCL) your advanced knowledge and solid understanding of clinical study design and drug supply processes, you will lead and manage matrix teams responsible for the end to end oversight of supply chain activities required for the provision of investigational product on phase I-IV protocols for both Small Molecule and Biologics programs. The SCL role requires you to provide consult on all aspects of investigational product strategies and a key decision maker for the development of investigational product supply and sourcing strategies.You are responsible for designing strategies that align with program, protocol, and regulatory requirements, identifying and managing supply chain risk, managing multi-million clinical supply budgets, and providing guidance and leadership to the Clinical Supply Team (CST).

The SCL, oversees the end-to-end activities and identifies potential risks, develops supply strategies that balance cost, timelines, and risks to support the development of candidates in the Pfizer Research & Development across the multiplre business units within Pfizer.

The SCL is accountable for Pfizer clinical supplies delivery and oversight of end-to-end process from API to finished product delivery to clinical sites. This role requires a thorough understanding of processes, production cycle times, strategies, challenges, risks and constraints of all supply chain functions.

The SCL is the key Global Clinical Supply (GCS) point of contact for clinical study teams, Co-Development Teams (CDTs), asset teams, and Clinical Research Organizations (CROs) and represents GCS at the core study team. The SCL provides study teams with innovative solutions to clinical drug supply production, packaging, labeling and distribution in order to influence clinical study design and drive successful execution.

The SCL is the matrix team lead of the GCS CST and provides broad consult on all aspects of clinical drug supply.

Key Responsibilities

Clinical Supply Strategy:

• Responsible for leading the development and execution of investigational and commercial material global supply strategies for early and late stage development programs intended for regulatory approvals of new products, new indications, or line extensions of currently approved products.

• Participate as a key member of the Pharmaceutical Sciences Project Team (PSPT) and Co-Development Team (CDT) to proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives.

• Participate as a core study team member to provide operational knowledge relating to Investigational Product (IP) and lead strategy discussions to align with protocol and operational needs for each study. Proactively anticipate changes based on operational factors (countries, sites, enrollment), randomization configuration and protocol requirements

• Proactively anticipate changes based on operational factors (countries, sites, enrollment), randomization configuration and protocol requirements.

• In partnership with the CST, develop clinical supply solutions, including packaging, blinding, and distribution strategies, that meet the needs of clinical studies as well as ensure patient compliance and safety.

• Proactively identify risks and develop strategies to mitigate these risks and create contingency plans that minimize the impact of unanticipated events

• Manage clinical trial drug supply budget and communicate forecasts and changes effectively and in a timely fashion to study teams and GCS partner lines.

• Maintain project information in GCS project tracking systems and in PharmSci project management systems.

• Ensure site and patient focus, along with quality compliance, throughout PharmSci and GCS

• Act as a point of contact for clinical supply required input during audits and regulatory inspections as well as participate in inspection readiness activities.

• Participate on Limited Duration Teams and Continuous Improvement projects.

Matrix Team Leadership:

• The SCL is the matrix team lead of the MedSci GCS Clinical Supplies Team (CST) and provides broad consult on all aspects of clinical drug supply.

Basic Qualifications:

• Applicant must have a bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• Demonstrated ability to manage large and complex clinical development programs.

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