ROLE SUMMARY

Operational Strategy Lead (OSL) role is a member of the Global Clinical Supply Operations (GCSO) (part of the Clinical Development & Operations Global Clinical Supply group).

Our purpose is to provide clinical packaging, labelling, and logistics solutions to deliver quality patient-focused clinical supplies to the patient.

GCSO provide quality clinical supplies in a compliant, timely, innovative and cost-effective manner. We continuously strive to improve our systems, processes and capabilities in collaboration with our internal Pfizer and external partners in support of developing breakthroughs to change patients’ lives.

Operational Strategy Leads are accountable for developing an integrated end-to-end CSO operational strategy for Pfizer clinical programs and clinical studies.

OSLs partner with Supply Chain Leads (SCL) and Clinical Research Pharmacists (CRP) closely to develop comprehensive and patient-focused operational strategies for their assigned programs.

OSLs are accountable for implementing the operational strategy delivering clinical supplies to support the clinical studies for their assigned programs. OSL achieves excellence by focusing on patients, working with integrity, and professionalism.

OSLs utilize knowledge of Supply Chain process, their expertise in clinical supply packaging, labelling, distribution, and project management skills to establish comprehensive operational strategies and collaborate with internal and external partners to deliver clinical supplies to support clinical studies. OSLs work closely with other functional roles in GCSO and across GCS and Quality Assurance (QA) to ensure timely and accurate execution of clinical packaging, labelling, and distribution operations.

Substantial training is provided to ensure OSLs can perform all duties and tasks an OSL is accountable and responsible for.

OSLs proactively manage risks through risk identification and risk mitigation plans and have detailed execution and monitoring plans to enable the overall design input on a program basis and effective execution of clinical supply packaging, labelling, and distribution.

KEY RESPONSIBILITIES

• The Operational Strategy Lead (OSL) is accountable for developing and implementing mid-to long-term supply chain strategies for assigned programs and initiatives. This includes forecast and execution of key packaging, labelling, distribution, and logistics events. The OSL is also accountable for monitor the effectiveness of their operational strategies, and partnering with functional lines in Clinical Supply Operations (CSO) to ensure seamless implementation of operational strategies and delivery of clinical supplies.
• OSLs represent GCSO on Clinical Supply Team (CST) for their assigned programs.
• OSLs are responsible for ensuring that the overarching strategy & scenario planning for the program/protocol is developed with and shared within appropriate stakeholders.
• OSLs monitor and provide input to GCSO level program/protocol dashboards (one dashboard) part of program management support.
• OSLs directly oversee delivery of GCSO activities (clinical packaging and labelling operations and trial distribution) to ensure that all clinical study timelines are support and met.
• Ensures GCSO inspection readiness as part of program management support.
• Participates or leads GCSO strategic and/or Continuous Improvement (CI) initiatives.
• Provides program-level forecast and special needs to vendors.
• Provides packaging, labeling, and distribution/storage cost estimation.
• Support integration activities when needed.
• OSL is the GCSO point of contact with Supply Chain Leads (SCL) and Clinical Research Pharmacist (CRP) on GCSO operational strategy. Projects will be assigned at a program level. This position, working independently and influencing others without having a direct reporting relationship, coordinates the fulfilment of customer requests while providing excellent customer service. This role strives to utilize technology and industry trend information to proactively contribute to improving effectiveness of integrated packaging, labelling, and distribution strategies.
• Develops positive and collaborative partnerships with key stakeholders across partner lines. Proactively ensure quality and compliance through risk identification and mitigation plans, strategic planning and execution, and overall design input.
• Assists GCSO Leadership with strategic development of CSO roles to support evolving needs of stakeholders and patients.
• Evaluates current processes and make recommendations for continuous improvement in the packaging and distribution operating models.
• Supports fiscal accountability to projects by refining project specific costs.
• Partners with CSO functional line leaders to further develop/refine human resource capacity analysis for CSO to align resource with project needs according to portfolio priorities
• Ensures compliance with all legal requirements (e.g., EHS, cGMP, GCP, import/export, Quality Standards, 21 CFR Part 11) by creating and maintaining a culture committed to quality; accountable for maintaining training and compliance required for the role; enhance quality and compliance on a site and patient basis utilizing risk and mitigation plans; and assess cross functional impact of procedure/ process changes to CSO processes.
• Interfaces directly with GCS and other groups across Pfizer in order to provide timely and responsive guidance and issue resolution regarding clinical packaging and distribution activities.
• Establishes Program level integrated GCSO operational strategies with Clinical Supply Teams (CST). Contribute to decisions on country feasibility and strategy discussions well in advance of the protocol decisions. Ownership of timing and challenges on country movements in order to meet project requirements.
• Ensures excellent customer service through the development of strong working relationships with key customers and partners leaders to facilitate open lines of communication regarding project priorities, and issue resolution.
• Triage issues and provide appropriately detailed updates to CSO leadership.
• Utilizes project management skills to develop robust packaging and distribution/ logistics planning and management tools; optimize operational strategy to ensure patient continuity; high quality project oversight and activity review.