Manager of Clinical Supplies

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

Trial Supply Planning (TSP) services, provides planning system configuration, kit demand, and supply network planning services for  a portfolio of clinical trials and compounds

What do you need to Have:

• Services rendered will adhere to applicable SOPs, WIs, study protocols, and relevant training requirements.
• Takes ownership of planning related activities from CSI/TSM or TSP per transition plan. Thoroughly reviews transition checklist, clinical study designs and pre-configured system specifications.
• Manage planning master data and parameters across systems and documents (e.g. kit type/brightstock descriptions, label groups, DNS, shelf-life, pack life at depots, safety stock, BOM configuration).
• Acts as the bright stock owner for studies that have adopted Just-in-time (JIT) labeling, overseeing planning of bright stock, advising on bright stock strategy, and maintaining the bright stock order form (BSOF)Using forecasting and simulation software (Optimizer), with support from the systems team and inputs from CSI/TSM, build or maintain kit demand planning models that reflect all study assumptions, including dosing schedule, distribution network, enrolment forecasts, and actuals
• Identify and recommend optimal IWRS site resupply strategies and predictive resupply algorithms
• Forecast the global kit demand, from first site opened (FSO) to last patient dosed (LPD).
• Using supply planning software (OMP+), plan depot transfers and packaging campaigns to maintain safety stock targets at depots and sites, ensuring shelf-life and label constraints are accounted for. Adhere to the clinical S&OP cycle, continuously assessing current inventory, forecasts, BIAS/MAPE, and adapt supply planning accordingly in order ensure successful dose while minimizing scrap.
• Attend cS&OP (Pre-Demand / Demand / ID&S) meetings to ensure cross CSC alignment on study assumptions, kit demand requirements, DP/API capacity constraints, and allocations.
• Attend P&L Ops meetings to ensure alignment on P&L requirements, timelines, and bright stock strategy.
• Attend kit reliability room meetings to voice impacts of delay and prioritize orders during capacity constraints.
• Develop scenario plans to drive decision making and budgeting. Perform detailed analysis on supply risks, documenting and ensuring transparency to management team and study partners.
• Account for the Pack & Label and Distribution budgets. Ensure budgets are updated to reflect shifts in supply plans. Advise study partners of budget status, including risks, and significant changes.
• Manage demand, supply, and inventory issue resolution at the study and compound level.

Education and Work Experience:

• Bachelor degree REQUIRED.
• 4 Plus years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
• Supply Planning experience Highly desired.
• Drug Forecasting or Demand Planning experience nice to have.
• Some Packaging and labeling experience desired.
• Sample kits, API's, Raw Materials, or Clinical Trial Drug Supplies experience highly desired.
• cGMP experience desired. 

Knowledge, Skills, and Abilities:

• Working knowledge of the Clinical Trial Supply process
• Working knowledge of project team structure and processes
• Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
• Knowledge of project management and Clinical customer relationship building
• Knowledge of the ‘Customers’ team structures and processes
• Excellent verbal and written communication skills
• Ability to influence others
• Ability to multi-tasks
• Strong organizational skills
• Experience in conflict resolution and negotiation skills
• Some Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access).

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.