Director, Precision Medicine, CDx
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.
The 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 define strategy, implement and ensure appropriate CDx development timelines are met. Further, the successful candidate will be a strong leader with excellent communication and collaboratative skills and work well in a team based environment.
Essential Functions required for the job-
• Define CDx strategy and effectively gain alignment across relevant stakeholders (including senior management) within Regeneron.
• Lead implementation and execution of Regeneron CDx strategy in collaboration with key stakeholders.
• Responsible to evaluate and make decisions on technologies and vendors as needed to support diagnostic and program deliverables.
• 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).
• Responsible to guide and review assay validation packages and testing lab clinical trial conduct (GLP, CAP, CLIA)
• Be able to 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, 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.
•Ph.D., or equivalent experience. Advanced degree strongly preferred.
•Minimum 10 years pharmaceutical or diagnostics industry experience preferred.
•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 4 years Companion Diagnostic experience in drug development setting and demonstrated working knowledge and leadership in this space.
•Experience in biomarker discovery and development desired.
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.