Associate Director, Precision Medicine, CDx

Location
Tarrytown, NY, United States
Posted
Oct 29, 2020
Ref
22089BR
Required Education
Bachelors Degree
Position Type
Full time
As an Associate Director, Precision Medicine will work closely with Sr. Director to ensure delivery of quality biomarker and companion diagnostic data and strategy. We support the portfolio from exploratory analysis to CDx/PMA approval. We support Precision Medicine Scientists, Precision Medicine Operations and Companion Diagnostics as well as relevant partners in Procurement, Regulatory IVD, Clinical Operations, Vendor Management and Quality Assurance. You will also be building knowledge of and relationships with IVD sponsors and testing labs world-wide as well as being a source for industry trends and business development efforts.

A typical day may include:

Oversight and visibility into external laboratory vendors and assist with balance and management of the outsourcing portfolio across both CDx and biomarkers. You will be expected to deliver planning and execution for balancing the portfolio and importantly ensuring companion diagnostic strategy is prepared end to ensure long term program success. This element requires successful planning and communication at a Sr. Management level. Furthermore, your will lead with excellent communication and collaborative skills to work well in a team-based environment.
  • Support companion diagnostic assay development, validation, patient enrollment and sample analysis activities.
  • Maintain oversight of CDx contracts, project deliverables and manage invoice review.
  • Develop and maintain process for oversight of biomarker laboratory analysis at external vendors
  • Responsible for contract oversight and management of key milestones internally and with relevant laboratories.
  • 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 both from a day-to-day and strategic perspective. Proactively identify and mitigate risks.
  • Provide testing site implementation and oversight for biomarker/CDx programs from contracting to sample logistics to data delivery.


This may be for you if:

Have the ability to work in cross- functional teams and present complex strategies successfully.
Desire to see an impact on patients and drug development
Have strong operational abilities with the understanding of clinical trial implementation, managing timelines and communicating effectively both externally and internally.
Demonstrate strong leadership skill and can effectively work collaboratively with vendors and internally to ensure program success.

To be considered for this you should have a Bachelor's degree and over 8 years of pharmaceutical or diagnostics industry experience. Experience in execution of clinical trials, sample logistics and data reporting are required as is experience contracting and demonstrated success building business relationships is required. Your experience will need to include defining and executing strategic decisions regarding companion diagnostic development. Your experience should also include relevant knowledge of the regulatory requirements surrounding CDx (from study set up to PMA filing.

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.