Executive Director

The Global Program Head, Ophthalmology leads and drives the creation of an integrated program strategy through engaging with and including information from all relevant key stakeholders. The Global Program Head is also responsible for ensuring Executive Management has the right information, via discussion and presentations, to authorize final program strategy decisions. The Global Program Head also leads the strategic program team for each asset and is responsible for program oversight and execution.

This role will be responsible for bringing all of Regeneron’s Ophthalmology development program(s) forward from pre-IPA nomination through BLA application, including multiple pre-IND/CTA molecules under development and new indications and life cycle management of currently approved therapies including aflibercept (VEGF inhibitor). These include novel therapies and therapeutic modalities for many serious ophthalmic diseases, including glaucoma, uveitis, corneal dystrophies, dry eye and inherited retinal disease. This role has a broad impact, and interacts with almost all areas within the company, including research, non-clinical development, medical safety, medical affairs, clinical development, program management, finance, business development, regulatory, commercial, and industrial operations (manufacturing) to identify and devise development strategies for programs and ensure their successful execution.

As Global Program Head a typical day might include the following:

• Identifying and aligning all of the key partners across Regeneron (and partners, as needed) and ensuring they are engaged and included as part of program strategies.
• Providing sound strategy guidance for program therapeutic area development strategies inclusive of research, clinical, regulatory, supply (includes tox, clinical and commercial materials) and commercial needs.
• Ensuring that scientific rigor and innovation continues to be integrated into and drives our program development strategies.
• Driving broader cross functional perspective in developing program strategies including scientific rationale, operational feasibility, budget, timeline, and an understanding of the competitive and commercial landscape.

Key Responsibilities:

• Builds and leads Strategic Program Teams (SPT) in the development of the long-term, end-to-end integrated program strategy and target product profile that maximizes the chance of success of the program through the development process. Is expected to be to be both the best advocate and critic of the program and its future development within Regeneron
• Provides feedback and input to the functional strategies including research, clinical, regulatory, supply (includes toxicology, clinical and commercial materials) and commercial
• Ensures that scientific rigor and innovation continues to be integrated into and drives the integrated program strategy
• Orchestrates the execution of SPT deliverables and the SPT’s governance interactions, representing the SPT and program strategy
• Oversees and holds sub-teams and their leads accountable to execute on the program strategy, development plan and timelines. Is responsible for cross-functional issue identification and resolution
• Proactively helps identify new opportunities / targets
• Maintains a full financial perspective of the program budget and future development cost and takes an active role in managing the financial resources of the program
• In close collaboration with the development program manager, prepares and leads SPT meetings including creation of agenda and list of participants, enforces meeting norms, ensures effective decision making and is responsible for communication of key decisions and developments vis-à-vis all relevant non-SPT members
• Oversees risk identification, assessment, and mitigations activities; makes effective decisions on addressing issues after gathering cross-functional input
• Identifies and aligns with all key stakeholders across Regeneron (and partners, as needed) and ensures they are engaged throughout the program lifecycle
• Coordinates the program’s progression at key transition points (e.g., submission / launch)
   

This role might be the right fit for you if you have the following:

• MD, PhD, or PharmD
• 10 + years' experience with broad drug development in ophthalmology
• Deep scientific and clinical knowledge across a broad range of ophthalmic diseases such that interaction and contribution across the spectrum of Discovery through late state development is achieved
• Deep knowledge and substantial expertise in the overall development of molecules for ophthalmic diseases
• Proven track record in leading a program forward through development milestones and/or approval in a biotechnology/pharmaceutical company; experience or knowledge of biologics and alternative therapeutic modalities including siRNA, CRISPR, antibody-drug conjugates preferred.
• Expert knowledge of the competitive landscape and general regulatory requirements for drug approval
• Must be able to deeply and rigorously interpret clinical and preclinical data
• Ability to design development strategies with the team and convey and implement those strategies
• Ability to holistically view the development pipeline and to develop strategic and tactical plans for programs in development and management of the lifecycle of approved compounds based on this view