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Associate Director, CDx Precision Medicine

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
Sep 19, 2019

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Discipline
Clinical, Clinical Trials
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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.

Summary:

The Associate Director, Precision Medicine will work closely with Sr. Director, Precision Medicine, the companion diagnostics team and key cross-functional stakeholders to deliver Companion Diagnostics (CDx) at Regeneron. The successful candidate will have CDx experience and be able to support vendor selection, contracting, management to implement and ensure appropriate CDx timelines are met. Further, the successful candidate will be a strong leader with excellent communication and collaborative skills and work well in a team based environment.

Responsibilities:

• Support implementation and execution of Regeneron CDx strategy in collaboration with key stakeholders.

• Manage companion diagnostic partnerships to ensure that the clinical study, IVD sponsor and laboratory timelines are coordinated.

• Responsible for contract oversight and management of key milestones internally and with CDx partners.

• Provide laboratory vendor support, by providing clear communication, tracking of timelines and proactively ensuring quality and program success.

• Prepare agendas, manage relevant meetings, and document the key decisions and action items. Be able to guide meetings and action items both from a day-to-day and strategic perspective. Proactively identify and mitigate risks.

• Build and maintain positive partner relationships.

• Communicate clearly internally updates and risks for CDx programs.

• Provide testing site implementation and oversight for CDx programs from contracting to sample logistics to data delivery.

• Oversee operational aspects of CDx clinical trial implementation, manage timelines and communicate effectively both externally and internally.

• Have relevant knowledge of the regulatory requirements surrounding CDx (from study set up to PMA filing).

• Be knowledgeable of industry trends, new technologies and global regulations surrounding CDx.

• Have effective project management skill-sets.

• Possess strong leadership tendencies, be able to proactively identify problems, determine resolutions, set priorities, direct projects and work cross-functionally to manage expectations.

• Demonstrate strong leadership and possess high level of emotional intelligence and effectively work collaboratively with vendors and internally at Regeneron to ensure program success.

Requirements:

Ph.D., or equivalent experience. Advanced degree strongly preferred.
Minimum 8 years pharmaceutical or diagnostics industry experience.
Excellent written and verbal communication skills are essential, experience in cross- functional teams and the ability to present complex strategies successfully.
Must have experience in execution of clinical trials, sample logistics and data reporting.
Must have at least 6 years of central laboratory management either internally managing within a central lab or management of outsourced laboratory work.

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

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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