Sr. Manager, Clinical Scientist, Oncology
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, NJ
- Start date
- Nov 12, 2019
View more
- Discipline
- Clinical, Clinical Research, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Summary:
The purpose of this position is to assist in the review and summary of clinical data for submission and publication purposes. In addition, this person may assist in the development and/or review of clinical study documents including but not limited to protocols, CRFs, IBs, DSURs, and study manuals as needed.
Responsibilities:
• Support clinical oncology study teams with analysis of trends, safety and efficacy, quality check clinical data periodically and query issues
• Review study related documents such as data management plan, eCRF completion guidelines, data validation manuals, database UAT
• Draft and review clinical sections in regulatory and clinical documents such as study protocols, DSUR, investigator's brochure, PIP application, conference abstracts, slides for presentation
• Assist with planning and setting up of meetings with external experts - Ad board, consulting and steering committees
• Writes and presents well-reasoned reviews and proposals to cross-functional project teams
• Engage in team discussions and provide support for assigned projects
• By collaborating with interdisciplinary teams, develop and optimize REGN's indication knowledge base/dashboard to facilitate information sharing across the organization
Requirements:
• Must have an excellent understanding of oncology clinical data. Ability to conduct detailed review and analyses of clinical data and to generate queries as needed to ensure that we have data that is clean and submission ready. Must be resourceful and have outstanding abilities to synthesize and make connections
• Assists in the development of portions of key documents for clinical programs
• Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engages in team discussions and provides translational sciences support for assigned projects
• Outstanding communication skills, both oral and written.
8-10 years in a clinical research environment.
Education:
Bachelors Degree.
Masters and/or PhD preferred.
SKC, #LI-SC1
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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