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Job description
Site Name: Belgium-Wavre, Stevenage, UK - Hertfordshire - Stevenage, Upper Providence, USA - North Carolina - Zebulon, USA - Pennsylvania - Upper Providence, Ware, Zebulon
Posted Date: Feb 5 2025
About the role
The Senior Portfolio Manager ensures an end to end logistic oversight at asset/study level covering activities from forecasting until IMP reconciliation. As Clinical Supply Chain (CSC) SPOC, the Sr Portfolio Manager (PFM) is responsible for the timely availability of IMPs for clinical studies.
This role is responsible for influencing clinical plans relative to investigational product (IP) supply and determining optimal supply strategies that are patient-focused, risk-adjusted, and aligned with GSK ambitions.
The Sr PFM oversees supply chain performance to ensure the successful execution of the supply chain.
About the responsibilities
* CSC Project Management for different assets
* Challenges key assumptions and Clinical planning parameters while influencing clinical study proposals to ensure optimal cost / risk / benefit tradeoffs.
o Influences partners to ensure that clinical development strategy, planning and execution are aligned with delivery of an efficient supply chain with optimized utilization and agreed risk profile in alignment with GSK ambition.
o Aligns cross-functional supply teams on the challenges, assumptions and constraints of the clinical supply chain and ensures supply scenarios and risks are explored and agreed.
o Influences team decisions to maximize the use of resources/materials.
o Mitigates and manages supply chain risks, ensuring continuity and security of supply while working within the confines of the current regulatory environment.
* Designs and executes supply chain strategies that deliver on the GSK R&D ambition while ensuring consistent on-time delivery of medicines to patients.
o Conduct clinical supplies forecasting, long and short term.
o Feasibility & risk assessment at asset/study level.
o Link with planning, operations for feasibility evaluation of clinical supply operations.
o Review and input on Concept Protocol.
o Conduct lot allocations for studies and manage (re)supplies.
* Works with business partners to oversee the effective execution of supply chain plans while proactively identifying potential obstacles to success and taking action to resolve issues.
o Logistic oversight from forecasting till IMP reconciliation.
o CSC Point of contact for clinical supplies and distribution, including planning and trouble shooting.
o Follow-up of milestones to ensure the timely release of clinical supply to ensure IMP availability in accordance with the needs.
* Create, lead, influence and manage cross-functional teams, including external groups, to co-ordinate and manage the delivery of clinical supplies for specified GSK asset(s) at the asset level.
o Communication up through GMP Mfg leadership and out to key stakeholders.
o Accountability for CSC group at asset level in CMC model.
* Be accountable for complex 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.
* Identify and lead process improvements projects when needed.
* Develop and manage clinical supply budgets.
* Support clinical sites and site audits, as needed.
* Handle KPI reporting.
About you
* B.S., M.S., Pharmacy, Chemistry, Engineering, Logistics or related scientific or supply chain discipline or equivalent experience in relevant field.
* Strong Project/Program Management skills (experience required, certification is a Plus).
* Strong leadership, communication and interface management skills, including strong partnership behaviors that enable transparent communications and team alignment.
* Experience with global supply chain design and logistics management, preferably in clinical trials.
* Demonstrated ability to lead and to influence global cross-functional teams.
* Knowledge in the management of clinical trial supplies including, but not limited to product manufacturing, planning, forecasting, inventory management, clinical packaging and distribution.
* Understanding of investigational product supply requirements for international studies, including knowledge of global regulatory requirements, including cGMPs, ICH and GCPs.
* Ability to maintain accurate records and files in accordance with cGxPs and SOPs.
* Excellent knowledge of written & spoken English - knowledge of French is an asset.
* APICS or CPIM certification / Lean Sigma certification/experience is a +.
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