Associate Director, Comparator Clinical Supply Strategy
The Associate Director of Comparator Supply Strategy is responsible for leading comprehensive clinical comparator supply and sourcing strategies at the asset, program and study levels spanning long-range planning through labeling of comparator supplies for clinical trials. The incumbent will drive standard methodologies, standardization and optimization of comparator supply strategies and planning processes. As part of the Clinical Drug Supply & Logistics (CDSL) leadership team, the Associate Director collaborates with both internal and external partners, including Regulatory, Industrial Operations, Clinical Operations, Procurement, and Clinical Finance to develop and drive the implementation of comparator supply strategies in clinical trial settings.
- Responsible for defining study-specific supply strategies for global trials based on regulatory requirements and market availability. Collaborates with Regulatory Intelligence to identify and interpret applicable regulations with respect to labeling requirements at both the country and local levels.
- Collaborates with external Supplier and Procurement to perform financial evaluations of cost-effective sourcing alternatives. Performs and communicates risk/benefit analysis for various scenarios and suggests risk mitigation strategies. Implements the most 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. Responsible for 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 partners and align on logistical details to ensure a seamless transition from concept to operational implementation.
- Reviews and communicates general trade regulations governing import/export for global regions, as required
- Support and facilitate specific comparator client contracts, CDA’s, MSA’s and Technical Supply Agreements.
- Evaluates potential distribution network optimization based on market availability of comparators in specific countries taking into consideration regional variations of comparators including dosage form, strength, API concentration, visual and packaging presentations. Provides costs and risk/benefit analysis for the various presentations.
- Leads all aspects of comparator budgets at a portfolio and study level. Ensures timely review and approval of initial budget and runs the budget through the lifecycle of the program by communicating changes to Clinical Operations team as appropriate.
- Responsible for supplier/vendor-related relationship management and acts as a point of escalation for performance issues.
- Build strong, enduring relationships with collaborator groups to create a culture of dedication and act as key escalation point for internal customers and cross-functional partners.
Bachelor's degree required. Degree in supply chain or related drug development field or equivalent qualification or experience
- Extensive experience (10+ years) working in clinical supply chains with specific experience in management of comparator products
- Extensive knowledge of the EU Clinical Trial Directive, Good Clinical Practice (GCP) and global regulatory environment impacting the provision of comparator products
- In depth knowledge of R&D supply chain and drug development process
- Extensive experience in managing comparator 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.
- Deep understanding of strategies that drive efficient comparator sourcing, including:
- Sourcing from low-cost markets, pooled supplies, JIT labeling, On-demand procurement
- Deep understanding of supply chain networks, clinical regulations, timelines and analytics to facilitate communications to leadership in IOPS and 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 partners; creativity to aid in establishing robust business processes related to the forecasting function.
- Strong leadership skills; 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 and demonstrated vendor management experience.
- Strong people management skills including coaching, mentoring and development.
- Deep knowledge of GCP and ICH.
- 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.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.