Associate Director, Precision Medicine, CDx

Location
Tarrytown, NY, United States
Posted
Jun 28, 2019
Ref
16527BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
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:
Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. As part of this initiative, the Precision Medicine team in Early Clinical Development & Experimental Sciences (ECD&ES) is integrated with Discovery Research teams to promote early adoption of biomarker strategy to guide clinical translation and collaborates with Clinical Sciences colleagues to develop the clinical experimental sciences (CES) studies for generating clinically testable, mechanistic hypotheses for each molecule. Precision Medicine leads the biomarker strategy and execution to achieve proof of mechanism/concept in early clinical trials. The team also implements Precision Medicine strategies to support late-stage clinical programs and companion diagnostics. Our team includes Precision Medicine Strategy Leads, Precision Medicine Operations specialists, as well as quantitative analytical and companion diagnostics scientists.
The Associate Director, Precison 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.

Job Duties:

Essential Functions required for the job-

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

• Manage companion diagnostic partnerships to ensure that the development timeline, regulatory path and commercialization plan for CDx are coordinated.

• Responsible to support vendor selection process from a business development/contracting perspective as needed to support diagnostic and program deliverables.

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

• Provide alliance managent support for companion diagnostic partnerships

• 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 2 years Companion Diagnostic experience in drug development setting and demonstrated working knowledge and leadership in this space.

• Experience with contract negotiation and alliance management as well as an understanding of CDx commercialization.

#LI-SC1, SKC

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.