職位描述
工作職責(zé):
JOB SUMMARY
Through a solid understanding of clinical study design and drug supply processes and risks, the Supply Chain Lead (SCL) develops supply strategies that balance cost, timelines, and risks to support the development of candidates in the Pfizer Worldwide Research & Development (WRD), Pfizer Innovative Health (PIH) and Pfizer Essential Health (PEH) portfolio.
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. Requires a thorough understanding of processes, production cycle times, strategies, challenges, risks and constraints of all Medicinal Sciences (MedSci) 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 the MedSci GCS Clinical Supplies Team (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
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.
Utilize Digital Supply Chain tools and understanding of clinical development plans to project drug supply demand.
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. 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.
任職資格:
QUALIFICATIONSBasic Qualifications:
B.S. degree (or equivalent) is required. Advanced training in supply chain management, a scientific discipline, project management, or business administration is desirable.
Business English and Japanese skills are desirable.
Preferred Qualifications:
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
ORGANIZATIONAL RELATIONSHIPS
Report to a DBO Asia Team Lead
Liaise with key internal customer contacts (WRD, PIH, PEH) to gather clinical development plans, and review supply strategies.
Interface with Global Product Development (GPD) and/or CROs to lead supply strategy and execution associated with study management activities.
Build and maintain strong partnerships with Supply Chain workstreams and partner lines as the leader of the CST.
Interface with GPD Clinical Program Manager (CPM) to link program level supply strategy with contracted development efforts.
