Assoc Dir Clinical Comparator Drug Supply & Logistics

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.
  
  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 adequate level of guidance to other functional areas to empower them to make similar decisions to achieve common goals.


• Budget management experience.


• Demonstrated vendor management experience.


• Additional competencies include, knowledge of ex-US labeling requirements, shelf-life/stability management, global distribution, IRT technology, performance metrics development, project management, and I/E requirements.


In order to be considered qualified for this role, a minimum of Bachelors/Master's degree and 10+ years of Clinical Supply Chain experience is required.

• Degree in supply chain or related drug development discipline or equivalent qualification or experience


• Extensive experience (7+ years) working in clinical supply chains with specific experience in management of comparator products


• Extensive knowledge of the EU Clinical Trial Directive, Good Manufacturing Practice (GMP) and global regulatory environment impacting the provision of comparator products


• Knowledge of R&D supply chain and drug development process