Senior Medical Director, Clinical Sciences, Oncology
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.
The Senior Director, Clinical Sciences, will be responsible for providing overall clinical scientific leadership for a sizeable program including direct responsibility for clinical development strategy and execution of clinical trials. The incumbent will lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions and will directly manage Medical Directors and Clinical Scientists responsible for the design and execution of first in human through registration-enabling studies. This role will serve as the primary representative for the therapeutic area to a range of audiences, including executive leadership, development partners, and US and global regulatory agencies.
• Solid early development / proof of concept experience is required.
• Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Experience designing and developing smaller, yet robust and innovative Phase 2/3 programs.
• Prior experience interacting effectively and successfully with regulatory agencies is essential.
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products is required.
• Proven ability to represent the Company’s interests effectively in interactions with partners and regulatory agencies.
• Proven ability to “build a case,” both with internal scientific management and the Company’s partners / collaborators.
• Ability to lead a dynamic group in a fast-paced and hands-on environment.
• Effective written and verbal communications and interpersonal skills with all levels.
• Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making.
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• Change agent and driver capable of adapting to organizational growth, as needed. High energy with focus and vision; self-motivated, proactive and solutions-oriented.
• Experience in working with external collaborators, including CROs, national institutes and multinational pharmaceutical companies is preferred.
1. Recognized expertise in clinical trials
a. Working understanding of statistical principles, medical monitoring
b. Demonstrated ability to perform literature research, analyze and author clinical trial publications.
2. Has working knowledge of GCP, ICH, US FDA and EMEA regulations
3. Successfully conducted exploratory clinical and/or confirmatory development
a. Strong analytical and problem solving skills.
b. Is well organized has mastered complex medical/clinical development tasks.
4. Superior written and oral communication skills:
a. Scientific presentation environments
b. Corporate environments
c. Clinical team and clinical trial environments
d. Superior computer skills
5. Rigorous work ethics with focus on details and high quality results
6. Works effectively under pressure
7. Ability to work in matrix environment (“dotted-line” authority)
a. Able to lead by influence
b. Able to accurately, amiably and effectively work with teams and CROs
c. Able to foster commitment in team members (including those in CROs)
d. Able to build successful collaborations with internal and external partners
8. Able to manage clinical trial resources
a. Clinical trial budgets
b. Able to identify human resource needs
c. Able to make appropriate prioritizations to meet challenges
9. Able to develop original ideas
10. Available to travel (up to 20% of work time)
The Senior Director, Clinical Sciences, will have an M.D. or M.D./Ph.D., preferably with Oncology training. Minimum of 5 years of industry experience in clinical development, including experience with parenterally administered small molecules and biopharmaceuticals. Experience designing and executing first in human through registration-enabling clinical programs is required.
Prior leadership experience is required, prior managerial experience is preferred
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.