Assoc Dir Clinical Comparator Drug Supply
3 weeks ago
The Associate Director of Comparator Strategy and Operations is responsible for managing clinical comparator & ancillary supply and sourcing strategies at the asset, program, and study levels for Regeneron clinical trials. The associate director will be part of a team that drive best practices, standardization and optimization of comparator and ancillary supply strategies and planning processes. As part of Comparator Strategy and Operations team the Associate Director will collaborate with both internal and external stakeholders, including Global Development, Regulatory, Industrial Operations, and Clinical Finance to develop and drive the implementation of comparator supply strategies in clinical trial settings.
This role has a 3-day onsite requirement in either Basking Ridge, NJ, Armonk, NY, Uxbridge, London or Dublin Ireland. Full relocation is available.
**A typical day in this role might look like**:
Responsible for defining study-specific supply strategies for global trials based on regulatory requirements, timelines, and market availability.
Collaborates with Regulatory and CROs to identify and interpret applicable regulations with respect to market availability and sourcing options at both the country and local levels while taking into consideration regional variations of comparators including dosage form, strength, visual and packaging presentations.
Collaborates with external Suppliers and vendors to perform financial evaluations of cost-effective sourcing alternatives for study-specific supply strategies.
Performs and communicates risk/benefit analysis for various scenarios and suggests risk mitigation strategies to make sure comparators and ancillary supplies are not on critical path. Implements flexible and efficient supply strategy by evaluating fit-for-purpose strategic sourcing approaches.
Steers Strategic Program Team discussions pertaining to the comparator supply strategy and procurement to gain Senior Management alignment. Work with the comparator team to identifying supply risks and mitigation strategies to maintain supply continuity.
Investigate and develop supply strategies to be adopted at the portfolio level and/or treatment area based on aggregated analytics output. Communicate proposals to cross-functional stakeholders and align on supply chain details to ensure a seamless transition from concept to operational implementation.
Support and facilitate specific comparator vendor contracts, CDA’s, MSA’s and Technical Supply Agreements.
Assists director to manage comparator and ancillary supplies budgets at a portfolio and study level. Ensures timely review and approval of initial budget and manages the budget through the lifecycle of the program by communicating changes to Global Development and clinical finance team as appropriate.
Management of ancillary supply chain.
Build strong, enduring relationships with stakeholder groups to create a culture of high performance and act as key escalation point for internal customers and cross-functional partners.
**This role may be for you if you have**:
Extensive experience in managing comparator and ancillary supplies for global trials, including the ability to translate complex clinical trial designs into efficient supply strategies to meet business objectives.
Has a thorough understanding of global regulations governing comparator sourcing, including local requirements that may impact supply requirements for specific study sites.
Understanding of strategies that drive efficient comparator sourcing, including:
Sourcing from low-cost markets
Pooled supplies
JIT labeling
On-demand procurement
Knowledge of regulatory guidelines that affect the clinical supply chain. Know where to access regulatory references.
Deep understanding of supply chain networks, clinical regulations, timelines and analytics to facilitate communications to leadership in Global Development, and to develop cost effective clinical supply solutions balancing multiple business objectives.
Demonstrated ability to develop new ways of working; understanding of the function of forecasting in the supply chain in order to improve the value proposition to stakeholders; creativity to aid in establishing robust business processes related to the forecasting function.
Must be able to effectively communicate to all levels of the organization, including senior management.
Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
Ability to generate trust by demonstrating the highest level of consistency between communications and associated output. Maintains professional integrity in all areas of aspects of their work, especially under pressure.
Ability to provide solutions for diverse and complex supply chain issues simultaneously for multiple studies across various treatment areas.
Ability to implement supply strategies that align work with organizational priorities, even in ambiguous situations, and provides an a
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