1+ months

Senior Manager, Clinical Supply Chain Lead

Pfizer
Groton, CT 06340
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As a Supply Chain Lead (SCL), you will work at the intersection of Clinical and Pharmaceutical Development and be responsible for the end-to-end oversight of clinical supply chain activity. Your knowledge of the clinical supply chain, GxP regulatory framework and deep understanding of the dynamics and interdependence of both medicinal product and clinical development will be critical for the development of supply strategies to advance Pfizer's robust and diverse clinical pipeline.



The SCL will represent the Global Clinical Supply organization as a key point of contact to stakeholders across Clinical Operations, Pharmaceutical Development, Quality Assurance and Regulatory Affairs to advance the development of clinical assets. You will be expected to translate early and late-stage product strategies into a supply strategy which balances the needs of partnering organizations while ensuring supply continuity and a patient-centered focus. As the supply chain point of contact, you will provide broad consult on all aspects of clinical supply and be a key decision maker for the development of drug supply and sourcing strategies.



Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting of supply needs, and TMF filing of Clinical Supply documents.



The SCL will lead a matrixed team of subject matter experts from across Global Clinical Supply, including Packaging, Distribution, External Vendor Management, and IRT Management, as well as representatives from Quality Assurance, Regulatory Affairs and Pharmaceutical Development. The goal of these teams is to develop and implement innovative solutions to clinical drug supply and distribution challenges to meet the ever evolving and demanding needs of clinical trials. Through a solid understanding of clinical study design and drug supply risks, the SCL will guide the team to develop supply strategies that balance cost and risk without sacrificing patient safety.



This is a highly collaborative role with significant exposure across the pharmaceutical and clinical development spectrums. A successful Supply Chain Lead will utilize their skills in leadership, influence, negotiation, strategic planning, and project management to thrive in a matrixed environment, with the goal of delivering the highest quality clinical supply plans that are patient-focused, risk-adjusted and cost effective for the overall advancement Pfizer's first-in-class clinical pipeline.



**RESPONSIBILITIES**



**Operational**



+ Create, lead, influence and run cross-functional teams to coordinate and handle the delivery of clinical supplies for specified assets.

+ Participates in and may lead cross-functional program teams to meet all supply chain requirements and other strategic or continuous improvement goals.

+ Manage oversight of packaging, labeling, and distribution of clinical trial material for global clinical trials.

+ Generate multiple supply/ demand scenarios for Finished Good and or Investigational Medicinal Product (final labeled kits). Implement scenarios using appropriate analytical techniques, reporting capability/turning data into information.

+ Use knowledge of tools to increase productivity, manage complexity, and improve forecast quality.

+ Accountable for problem-solving and resolution of issues involving a range of technical, quality, regulatory and operational issues to ensure delivery to patient without compromising quality or cost.

+ Create Study Specific Technical Agreements (or equivalent) for specified projects.

+ Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.

+ Act as a consult on all information regarding the global use of investigational material in clinical studies: Forecasting, Packaging, Distribution, Inventory Management, Project Management and Financial Planning/Budgeting





**Strategic / Collaborative**



+ Working as a key member of the Clinical and Pharmaceutical Development Teams, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives.

+ Build relationships with and acts as a key resource and escalation point for within Global Clinical Supply lines as well as Clinical and Product Development lines

+ Translate strategic objectives into plans for team execution.

+ Exert influence on the overall objectives of planning and the clinical programs.

+ Build and maintain strong working relationships with Clinical and cross-functional program teams, including serving as the first point of escalation for issues related to clinical supply.





**Organizational**



+ Manage/support cross-functional projects such as cross-functional process/system integration.

+ Proactively identify and support Operational Excellence initiatives in Deliver including analysis of data and processes, assessments, business case development and pilot improvements

+ Operate with Integrity and by the Pfizer Values and Behaviors: Courage, Excellence, Equity and Joy





**Qualifications**



+ B.S. degree within a scientific discipline required with >10 years' experience in Pharmaceutical or Biotechnology Industry, 5 years in Biopharmaceutical Development, Manufacturing or Supply Chain Management preferred

+ Experience leading multi-disciplinary teams utilizing project management, negotiation, and strategic planning skillset.

+ Foundational understanding of end-to-end clinical supply chain activities.

+ Understanding of GxP concepts and impact to clinical supply.

+ Ability to develop forecasts and supply plans for investigational products incorporating expiry management and accounting for complex regulatory requirements.

+ Experience leveraging tools and systems to help with demand forecasting (eg. NSIDE, Bioclinica etc).

+ Experience with IRT systems and providing stakeholder input for IRT development.

+ Experience making data-driven decisions with the ability to interpret and present data clearly and effectively to partnering stakeholders.

+ Highly detail oriented with ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills.

+ Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc).

+ Ability to build positive relationships, ensure one GCS/Pfizer voice to both internal and external partners.

+ Effective collaborator who can bring together multiple stakeholders to develop and implement effective supply chain management strategies.

+ Change-Agile mindset who can thrive in a dynamic, complex, and regulated environment.

+ 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.





**Other Job Details:**



+ Additional Location Information: Role can be based onsite in Groton CT, La Jolla CA, Lake Forest IL, Andover MA, Chesterfield MO, New York NY, Collegeville PA, or North Carolina.

+ Eligible for Relocation Package: no

+ Eligible for Employee Referral Bonus: yes





**\#LI-PFE**



**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.



Logistics & Supply Chain Mgmt
Posted: 2021-04-28 Expires: 2021-07-08
Sponsored by:
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Senior Manager, Clinical Supply Chain Lead

Pfizer
Groton, CT 06340

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