Supply Chain Lead (Secondment 12-18 Months)

Pfizer•Andover, MA

1d•Hybrid

About The Position

WHY PATIENTS NEED YOU As a Supply Chain Lead, (SCL), 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. You will also provide consultation 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). WHAT YOU WILL ACHIEVE The SCL will oversee the end-to-end activities and identify potential risks and develop supply strategies that balance cost, timelines, and risks to support the development of candidates in the Pfizer Research & Development teams across the multiple 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 clinical 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 and MedSci functional lines 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 GCS Clinical Supplies Team (CST) and provides broad consultation on all aspects of clinical drug supply. HOW YOU WILL ACHIEVE IT 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 (PSPTI 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 lnvestigational Product (IP) and lead strategy discussions. 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 processes. 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: As the matrix team lead of the CST, the SCL will manage a network of internal and external partners to ensure GCS meets the customer expectations and supports the key Pfizer clinical study milestones and patient supply needs. Establish and maintain behavioral norms and performance expectations for the CST.

Requirements

BA/BS 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 breath 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.
Demonstrated ability to inspire teams to deliver in a dynamic business environment through effective change management and leadership.

Nice To Haves

MBA/MS with 7+ years of experience; OR PhD or JD with 5+ years of experience.
Demonstrated ability to manage large and complete clinical development programs.
Demonstrated capability to lead business development activities and acquisitions as they relate to clinical programs
Demonstrated in-depth experience managing multiple clinical studies in parallel.
Demonstrated ability to develop and maintain clinical supply demand forecast and budgets.
Relevant pharmaceutical experience.
Relevant operational experience across diverse business portfolio. e.g. Biopharmaceuticals, Consumer Products, other industries}
Past oral presentations at conferences and other large audiences.
Candidate demonstrates a 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 other colleagues to achieve meaningful outcomes and create business impact.

Responsibilities

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 (PSPTI 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 lnvestigational Product (IP) and lead strategy discussions.
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 processes.
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.
As the matrix team lead of the CST, the SCL will manage a network of internal and external partners to ensure GCS meets the customer expectations and supports the key Pfizer clinical study milestones and patient supply needs.
Establish and maintain behavioral norms and performance expectations for the CST.