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.
Demonstrated capability to lead business development activities and acquisitions as they relate to clinical programs.
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 in-depth experience managing multiple clinical studies in parallel.
Demonstrated experience leading and delivering in a matrix team environment.
Working knowledge of MS office applications, AI tools such as Copilot
Drug development, scientific research, or clinical study design including telerandomization, , pharmaceutical manufacturing/packaging/labeling/distribution/Import export..
Management of multi-disciplinary teams that includes measuring work, negotiation, conflict management, process improvement, project management.
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
Experience with budgeting and forecasting
Nice to Have Qualifications:
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.Experience with budgeting and forecasting
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Logistics & Supply Chain Mgmt
