Senior Manager, Supply Chain Lead

Why Patients Need You

Pfizer's manufacturing logistics and clinical supply chain team ensures that patients have the medicines they need when they need them. Colleagues in this role bring medicines to the world faster by embracing challenges, imagining what is possible and taking action. It is your dedication that will make it possible for Pfizer’s patients to receive the medicines they need, when they need them.

What You Will Achieve

Working with a dynamic team of Logistics and Supply Chain experts, the Senior SCL plays a critical role in overseeing and managing the operational aspects of ongoing projects. The Senior SCL serves as liaison between the project team and management. Your ability to influence teams will enable leadership of complex projects across the organization. Experience in project management is critical and will be used in reviewing status of clinical studies and budgets, managing packaging, labeling and distribution schedules, preparing status reports, identifying risk, and developing solutions and resolutions to meet productivity and quality. Your ability to develop and manage plans will facilitate achieving objectives, proactively identify roadblocks, interpreting internal and external business challenges and recommending best practices for improvement. While managing complex project environments, you will and troubleshoot as you use your and influence teams.

As a Senior Manager, Clinical Supply Chain Lead, (Senior SCL) your advanced knowledge and solid understanding of clinical study design and drug supply processes, will enable you to lead and manage matrix teams responsible for 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. This role provides guidance on all aspects of investigational product (IP) strategies and is a key decision maker for the development of IP supply and sourcing strategies.The Senior SCL is responsible for designing strategies that align with program, protocol, and regulatory requirements, identifying and managing supply chain risk, managing multi-million dollar supply budgets, and providing guidance and leadership to the Clinical Supply Team (CST).

In this role you will oversee all clinical supply chain activities and identify potential risks in program/protocol progress. The Senior SCL develops supply strategies that balance cost, timelines, and risk to support the development of candidates in the Pfizer Worldwide Research Development and Medicine Organization pipeline across multiple business units and therapeutic areas within Pfizer.

The Senior SCL is accountable for delivery of Pfizer clinical supplies and oversight of end-to-end process from API to finished product and distributed to clinical sites. The Senior SCL requires a thorough understanding of processes, production cycle times, strategies, challenges, risks, and constraints in all Medicinal Sciences (MedSci) supply chain functions.

The Senior SCL is the key Global Clinical Supply (GCS) point of contact for Clinical Study Teams, Co-Development Teams (CDTs), Asset teams, and represents GCS and MedSci functional lines as part of the Core Study Team. The Senior SCL provides Clinical Study Teams with innovative solutions to clinical drug supply production, packaging, labeling and distribution to influence study design and drive successful execution.

The Senior SCL is the matrix team leader of the MedSci GCS CST and provides guidance on all aspects of clinical drug supply.

Role 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 (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 clinical 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 such as the country and site recruitment, enrollment and randomization and protocol requirements.
• Lead the Clinical Supply Team (CST) and partner with its members to develop clinical supply solutions, including packaging, blinding, labeling 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.
• Effectively forecast clinical supply demand based clinical study designs, supply availability, expiry, and country footprint.
• Manage clinical trial drug supply budget and communicate budget forecasts and changes effectively and quickly 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 Global Clinical Supply (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.
• Serve as a point of contact for clinical supply required input during audits and regulatory inspections.
• Participate in inspection readiness activities.
• Participate, as required, on Limited Duration Teams (LDT) 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), Global Product Development (GPD), Clinical Supply Operations (CSO), Quality Operations, Import/Export, Global Chemistry, Manufacturing and Controls (GCMC), Clinical Research Pharmacists (CRPs) and other colleagues.

QUALIFICATIONS

• B.S. degree (or equivalent) is required.
• Advanced training in a scientific discipline, project management, or business administration.
• Seven or more years demonstrated and relevant experience in pharma/biotech project management and cross functional team leadership.
• Ability to manage large and complex clinical development programs.
• In-depth experience managing multiple clinical studies in parallel
• Capability to lead business development activities and acquisitions as they relate to clinical programs.
• Knowledge and experience working in a Good Manufacturing Practices (GMP) (cGMP) and Good Clinical Practices (GCP) (GxP) environment.
• Understanding of pharmaceutical/biotech quality and regulatory framework
• Experience leading and delivering projects in a matrix team environment
• Excellent Project Management skills in clinical supply chain environment and a working knowledge of MS office applications including MS Project and Office Timeline-Pro.
• Excellent computer, written and verbal communication skills.
• Breath of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, and to oversee and guide the work of colleagues to achieve meaningful outcomes and create business impact.
• Understanding of all phases of clinical drug development processes including late stage.
• Ability to develop and maintain clinical supply demand forecast and budgets.

PREFERRED QUALIFICATIONS

• Ability to inspire teams to deliver in a dynamic business environment through effective change management and leadership.
• Ability to coach and mentor others.
• Drug development, scientific research, or clinical study design including randomization, pharmaceutical manufacturing/packaging/labeling/distribution/import export.
• Management of multi-disciplinary teams that includes measuring work, negotiation, conflict management, process improvement, project management.
• Ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders.
• Experience working in a fast paced, dynamic, and complex environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

10% possible travel to other Pfizer sites

Other Job Details
Work Location Assignment:Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

Relocation assistance may be available based on business needs and/or eligibility.

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.