Pfizer Manager, Supply Chain Lead in La Jolla, California
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
- 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
- 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.
- Utilize Digital Supply Chain tools and understanding of clinical development plans to project drug supply
- Maintain project information in GCS project tracking systems and in PharmSci project management
- Ensure site and patient focus, along with quality compliance, throughout PharmSci and GCS processes.
Contribute to the investigation and implementation of corrective and preventative actions for Significant
Quality Events (SQEs) and Good Manufacturing Practices (GMP) Incidents.
Receive and assist in assessment of all clinical complaints.
Act as a point of contact for clinical supply required input during audits and regulatory inspections.
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 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, ensure open sharing of issues, engage team in solving problems, establish collective accountability for supply chain deliverables, ensure that team members are clear on their individual roles and responsibilities and regularly assess team performance. * Assess CST member strengths and through strong leadership motivate others to perform functional tasks to meet team goals. * Demonstrate teamwork by effectively interfacing and communicating with customers, GCS partners (Pharmaceutical Sciences Team Leads (PSTLs), Clinical Supply Operations (CSO), Quality Operations, Import/Export, Global Chemistry, Manufacturing and Controls (GCMC), Clinical Research Pharmacists (CRPs) and other colleagues.
B.S. degree (or equivalent) is required. Advanced training in supply chain management, a scientific discipline,
project management, or business administration is desirable.
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
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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.
Logistics & Supply Chain Mgmt