The Associate Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with Sr. Director, Precision Medicine CDx and key cross-functional stakeholders to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification and lead implementation and execution of CDx assays (from study conduct, sample management testing to launch) in collaboration with partners/IVD Sponsors and central testing laboratories in support of early and late-stage programs within our oncology and non-oncology pipeline.
As an Associate Director within Precision Medicine, a typical day may include the following:
- Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs to ensure program success
- Develop strong relationships partnerships with IVD partners and testing laboratories
- Oversee operational aspects of CDx clinical trial implementation, manage timelines and communicate effectively both externally and internally
- Have relevant knowledge of regulatory requirements and support regulatory teams surrounding CDx (from study set up to PMA filing)
- Be viewed as a subject matter expert in oncology and able to effectively communicate with clinical study teams on program direction
- Help 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
- 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
- Guide and review assay validation packages and testing lab clinical trial conduct (GLP, CAP, CLIA)
- Support audits of CDx testing laboratories
This role may be for you if:
- You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment
- Have CDx knowledge, demonstrated deep knowledge in science and technology
- You have effective project management skill-sets
- You demonstrate strong leadership skills and possess high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success
To be considered for this role, you must have a MS with minimum 6-7yrs or PHD with minimum of 5 years of experience. We are seeking technical and scientific expertise in diagnostic landscape, emerging technologies and commercial implementation considerations for patient selection assays to help drive innovation in CDx strategy at Regeneron. Be knowledgeable of industry trends, new technologies and global regulations surrounding CDx.
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. #GDECDJobs #LI-Hybrid