Executive Director, Strategic Program Direction - Oncology

Location
Tarrytown, NY, United States
Posted
Sep 03, 2020
Ref
20765BR
Discipline
Science/R&D, Oncology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Description: 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 eye diseases, high LDL-cholesterol, rheumatoid arthritis, atopic dermatitis, cutaneous squamous cell carcinoma, oncology, asthma, pain, and infectious diseases. The oncology portfolio is growing exponentially, and we have multiple oncology programs under development, including several candidates using our bi-specifics platform.
Summary:
The Executive Director Strategic Program Direction - Oncology drives the creation of an integrated program strategy for Oncology through engaging with and including information from all relevant key stakeholders. Secondly, He/She ensures Executive Management has the right information, via discussion and presentations, to authorize final program strategy decisions. He/She also co-leads the asset strategic team, and with their clinical co-leader, drives program oversight and execution.

This role will manage several REGN's Oncology programs from 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.
Responsibilities:
  • Interact and contribute across the spectrum of Discovery through late-stage development in Oncology.
  • Identify and align key stakeholders across REGN and ensure full strategic engagement.
  • Provide strategic guidance for Oncology program development including research, clinical, regulatory, supply (covering tox, clinical and commercial materials), and commercial needs.
  • Ensure that scientific rigor and innovation continues to be integrated into and drives development strategies.
  • Drive broader cross functional perspective and 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:
Opt-in documents
IND development strategy
Initial development plan
Full development plan
BLA filing and submission
Development Program review and REGN Sr. Management updates
Joint Strategy Committee updates
Program timelines
Annual and 3-year budgets and Life cycle management
Requirements:
  • 15 years minimum experience with broad drug development experience in oncology
  • MD, PhD, or PharmD required
  • Significant expertise in oncology clinical development
  • Proven track record in leading a program forward through development breakthroughs, filing, submission/approval in a biotechnology/pharmaceutical company; experience or knowledge of biologics preferred
  • Excellent communication and people leadership skills; must have the ability to concisely and cogently report to line and senior management the plans and outcomes for the program
  • Outstanding ability and skills to deal with ambiguity and work effectively with senior management and cross functional partners
  • Understand the competitive landscape and regulatory requirements for drug approval
  • Be comfortable working within a highly matrixed environment and influencing across functional areas outside of direct line management
  • Possess outstanding analytical abilities and can present to and hold their own with senior management
  • Ability 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 mitigation strategies
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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.