Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
The primary objectives of this role are multiple. First, this role drives the creation of an integrated program strategy through engaging with and including information from all relevant key stakeholders. Secondly, Strategic Program Direction is responsible for ensuring Executive Management has the right information, via discussion and presentations, to authorize final program strategy decisions. Lastly, Strategic Program Direction co-leads the asset strategic team and with their clinical co-leader, is responsible for program oversight and execution.
This role will be responsible for several REGN's I&I antibody program(s) forward from the lead selection through BLA application. This role has a broad impact, and interacts with almost all areas within the company, including research, non-clinical, clinical, medical safety, development, program management, regulatory, commercial, and industrial operations (manufacturing) to devise development strategies for an antibody program and ensure its execution.
- Deep knowledge of the I&I therapeutic area is required such that interaction and contribution across the spectrum of Discovery through late state development is achieved.
- Identify and align all of the key stakeholders across REGN (and partners, as needed) and ensure they are engaged and included as part of program development strategies
- Provide sound strategy guidance for program therapeutic area development strategies inclusive of research, clinical, regulatory, supply (includes tox, clinical and commercial materials) and commercial needs.
- Ensure that scientific rigor and innovation continues to be integrated into and drives our program development strategies.
- Drive broader cross functional perspective in the creation of program development strategies: scientific rationale, operational feasibility, budget, timeline, and an understanding of the competitive and commercial landscape.
- Adeptly translate development program strategies/ recommendations and concepts between the teams and senior management.
- Represent REGN at joint development committee(s)
Specific deliverables include:
IND development strategy
Initial development plan
Full development plan
ON-going deliverables are:
Direct line manager updates
Development Program review and REGN Sr. Management updates
Joint Strategy Committee updates
Annual and 3-year budgets and Life cycle management
- 15 years minimum experience with broad drug development experience in I&I
- MD, PhD, PharmD and/or equivalent years of experience
- Deep knowledge and substantial expertise in I&I clinical development
- Proven track record in leading a program forward through development milestones and/or approval in a biotechnology/pharmaceutical company; experience or knowledge of biologics 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 anticipate and identify risks and develop appropriate mitigation strategies
- Ability to work effectively with partner sand multiple stakeholders-both internal and external.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.