Vice President, Global Program Head - Ophthalmology

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 Regenerons 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 SPTs 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--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 programs progression at key transition points (e.g., submission / launch)
• Supports the professional development of SPT members and coaches the team to success
• Represent Regeneron at joint development committee(s)

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

• MD, PhD, or PharmD
• 10-15 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 build a team and drive a program forward-map out deliverables, ensure that the program(s) progress and stay on course, and lead cross-functional teams who do not report directly to him/her.
• Must be comfortable and have previous experience successfully working within a highly matrixed environment and influencing across functional areas outside of direct line management
• Excellent communication skills: must have the ability to concisely and cogently report to line and senior management the plans and outcomes for the program
• Must possess strong analytical abilities and be a critical thinker who can present to and hold their own with senior management
• 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
• Ability to anticipate and identify risks and develop appropriate mitigation strategies
• Ability to work effectively with partners and multiple stakeholders-both internal and external
  

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$300,000.00 - $500,000.00

Location: Tarrytown, NY, US

Posted Date: 11/27/2024