Scientific Director, Diagnostics

Location
Tarrytown, New York, United States of America
Posted
May 29, 2021
Ref
25022BR
Discipline
Quality, Quality Control
Required Education
Doctorate/PHD/MD
Position Type
Full time
As a Scientific Director, Diagnostics, you will collaborate with the Sr. Director, Precision Medicine, Companion Diagnostics (CDx) team and key cross-functional partners to deliver innovative Companion Diagnostics at Regeneron. Utilizing your sophisticated CDx knowledge and deep understanding in science and technology, you will lead diagnostic innovation for our patient selection strategies. You will be viewed as a subject matter expert in oncology as well as be able to support a wide range of therapeutic areas and able to effectively communicate with clinical study teams on program direction.
A typical day may include:
  • Defining innovative diagnostic strategies and to propose projects from idea to implementation taking into consideration all of the relevant inputs to ensure program success
  • Demonstrated strong relationships with IVD sponsors and testing laboratories.
  • Defining CDx strategy and effectively gain alignment across relevant partners (including senior management) within Regeneron to take concepts from idea to execution.
  • Lead implementation and execution of Regeneron CDx strategy in collaboration with key partners.
  • Continue to build knowledge and leverage expertise in technologies and and relationshiops with vendors as needed to support diagnostic and program deliverables.
  • Providing 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).
  • Responsible to guide and review assay validation packages and testing lab clinical trial conduct (GLP, CAP, CLIA)
  • Support audits of CDx testing laboratories.
  • 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, settle 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.
This may be for you if you:
  • Have technical and scientific expertise in diagnostic landscape, emerging technologies to help drive innovation in CDx strategy at Regeneron
  • Want to have a direct impact on patient lives
  • Are proactive and results oriented.
  • Have deep scientific knowledge and strong business acumen.

To be considered for this you must have a Ph.D., and a minimum of 10 years pharmaceutical or diagnostics industry experience. Your experience will include at least 4 years of Companion Diagnostic experience in drug development setting and demonstrated solid understanding and leadership in this space. Excellent written and verbal communication skills are crucial, with 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. Experience in biomarker discovery and development desired.

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.