The Supply Chain Lead (SCL) is the Global Clinical Supply Chain key point of contact for RU and BU customers, and DevOps Asset Managers. Responsible for liaising with Medical Development colleagues such as the Clinical Lead and clinicians for the purpose of managing clinical drug supply in Pfizer sponsored clinical studies. When acting as lead SCL for a commercial asset, the SCL must interact with the asset team and asset team leader.
Responsible for leading the development and execution of investigational material supply strategies for early and late stage development programs intended for regulatory approvals of new products and for new indications or line extensions of currently approved products.
Responsible for designing the appropriate clinical supply strategy, managing the supply chain risk and cost in alignment with the Clinical protocol, the BU/RU budget and regulatory environment.
Working as a key member of the PharmSci Project Team, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives.
Act as a subject matter expert on all information regarding the global use of investigational material in clinical studies. Accountability for Pfizer clinical supplies delivery and oversight of end-to-end process from API/DS planning to finished product received at the clinical sites.
The SCL is expected to translate early and late development product strategies into effective Supply Chain (SC) strategies. SC strategy is reflected in operating plans, inclusive of scope, time, cost, risk and communication plans which balance the needs of the customer and SC. Clinical supply delivery timelines are managed to maintain alignment with customer milestones. As one of the only Pfizer colleagues on the clinical team, the SCL must provide broad consult on all aspects of clinical drug supply. This means that the SCL is a key decision-maker during development of drug supply sourcing strategies and this can include assessments local sourcing managed by strategic partners.
Through a solid understanding of clinical study design and drug supply risks, the SCL must develop supply strategies that balance cost and risk and focus on patient safety. The SCL influences the team to adopt strategies that are right for the business through demonstration of extensive drug supply knowledge.
The SCL provides innovative solutions to clinical drug supply production and distribution and creates and implements these solutions through utilization of vendor resources for all aspects of supply.
The SCL utilizes the knowledge and skill of in-house vendor points of contact to drive successful execution of unit operations.
B.S. degree within a scientific discipline required
Greater than 10 years industry experience and 5 years of Clinical Operations, PharmSci, or related experience.
Biopharmaceutical development and/or clinical study support.
Management of investigational products at a clinical research unit or investigational drug pharmacy.
Management of multi-disciplinary teams that includes project management, negotiation, conflict management, and process improvement.
Proven ability to effectively develop, communicate, and execute project plans in conjunctions with multiple stakeholders.
Change management in a dynamic, complex, and regulated environment.
EEO & Employment Eligibility
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