Vice President, Oncology Clinical Development
Vice President, Oncology Clinical Development
Position Summary 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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Successful clinical oncology development in the age of immune therapy, personalized medicine and rapidly evolving biomarker and assessment tools requires an integration of the efforts of the very first trials of new agents and management of confirmatory registration trials. The boundary between traditional “early” and “late” development in oncology is blurred with the potential for rapid registration from first in human trials and emergence of profound biological insights from traditional larger confirmatory studies. Despite differences in day to day operational focus, sophisticated physician scientists developing new treatments for cancer must appreciate the span of this endeavor, and be comfortable working in a heavily matrixed and scientifically interdependent environment.
The VP will report to the Head of Oncology Development with primary responsibility to lead the advanced (Ph2 and Ph3) clinical development of REGN oncology assets. In addition to driving successful advanced development of the growing pipeline, the role includes being a thought partner with the Head of Oncology for innovative oncology development strategies, as well as a collaborator with preclinical researchers and developers of novel therapeutic agents, imaging and biomarker technologies and approaches.
This role also provides day to day people leadership to a large team of MD’s, most of whom are co-leaders of individual oncology assets spanning early POC to registration studies, and who are responsible for developing and driving oncology clinical development strategies for those assets. The VP will be a key representative for the more advanced oncology clinical development to a range of audiences, including executive leadership, development partners, and US and global regulatory agencies and will be a member of the Global Clinical Development Leadership team.
The VP will:
• Provide deep oncology drug development expertise to a rapidly expanding oncology portfolio that will cover many molecules and a multiplicity of Ab platforms, all developed and discovered within REGN.
• Provide sound oncology development guidance to key stakeholders across REGN (and partners as needed) and collaborate with other internal oncology development experts across REGN.
• Partner and collaborate closely with the Strategic Program Direction Leader for Oncology as the co-leaders for oncology assets under development
• Partner with the broader Global Development Organization to drive the execution of a broad oncology portfolio spanning many oncologic disease areas.
• Ensure that scientific rigor and innovation continues to be integrated into and drives all of our oncology development strategies.
• Excellent scientific standing among peers and the ability to address issues with a very high level of scientific rigor and creative solutions
• Adeptly translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study
• Develop a world class oncology development team; ensure that our MD team is being challenged and developed to be ready to take on new roles and programs as the portfolio matures
• May be expected to represent REGN at joint development committee as well as with global regulatory agencies(s)
Accountabilities: Key deliverables and measures of success
• Works closely with the Head of Oncology as to the best way to develop and prosecute the oncology portfolio
• Is able to drive the timely execution of multiple assets and studies within the oncology portfolio
• To ensure excellence in both strategy and execution, partners closely with clinical operations, biostatistics, data management, Program Direction and Research colleagues
• Is able to plan ahead to adequately resource the oncology development team as the portfolio grows and matures
• Partners closely with regulatory leaders to support regulatory submissions and develop regulatory strategies
• Keeps major stakeholders (Head of Oncology, Head of Global Clinical Development, Head of Regulatory Affairs) and other senior management updated as the portfolio evolves and matures.
• Guides the oncology MD’s to think broadly as they create innovative oncology development strategy options. Ensure all avenues and options have been explored and weighed before final recommendations are ready for review by senior leadership
• Mentors the MD’s in working with their asset co-leaders (SPD’s) as they co-create presentations for executive management that articulate the key rationale for recommendations and demonstrate innovative, strategic, as well as sound operational considerations.
• Provides robust career development plans for the oncology development team to ensure they understand how they can continue to develop their careers at REGN
• Ensures that the best practices and learnings from the wide variety of oncology programs are shared across the team to drive down the cases of “reinventing the wheel” and promote a vibrant collaborative atmosphere
Specific Role Competencies Required
o Scientific and Industry Acumen
Comes up with new and unique solutions that move the science and the asset forward
Is able to identify the most critical data points to appropriately drive innovative and effective solutions
Knowledgeable in current and possible future, trends, technology, policies, practices and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval
o Innovation Management and Development of Team Members
Is good at bringing the creative ideas of others forward and knows how to manage and cultivate the creative process of others; encourages diverse ideas and open conversations
Is aware of and provides challenging stretch assignments that are aligned with each person’s career aspirations; hold frequent feedback and development discussions.
o Planning and Communication
Accurately scopes out work for the team given the company priorities and needs
Sets and communicates goals to the team; identifies clear key milestones that are measurable and assessed frequently
Anticipates and adjusts as the situation changes; creates effective contingency plans
Keeps the team connected on key issues by using a variety of communication methods (including regular meetings)
• MD in Oncology or other related area, with at least 15 years’ experience working in the biotech and/or pharmaceutical industry; MD/PhD is a plus
• Deep oncology late stage development experience, in either small molecules or large molecules
• Understands the I/O large molecule world and platforms being developed in our industry
• Proven track record of strong collaboration skills and the ability to partner with others to devise innovative oncology development strategies
• Prior successful experience managing a large and complicated late stage oncology portfolio within industry
• Clear success in assembling, onboarding, managing and developing a large group of Physician and Clinical Scientists (Minimum
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.