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.
A typical day may include the following:
1. 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
2. Develop strong relationships partnerships with IVD partners and testing laboratories
3. Oversee operational aspects of CDx clinical trial implementation, manage timelines and communicate effectively both externally and internally
4. Have relevant knowledge of regulatory requirements and support regulatory teams surrounding CDx (from study set up to PMA filing)
5. Be viewed as a subject matter expert in oncology and able to effectively communicate with clinical study teams on program direction
6. Help define CDx strategy and effectively gain alignment across relevant stakeholders (including senior management) within Regeneron
7. Lead implementation and execution of Regeneron CDx strategy in collaboration with key stakeholders
8. Evaluate and make decisions on technologies and vendors as needed to support diagnostic and program deliverables
9. Provide testing site implementation and oversight for CDx programs from contracting to sample logistics to data delivery
This role may be for you if:
10. 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
11. Have CDx knowledge, demonstrated deep knowledge in science and technology
12. You have effective project management skill-sets
13. 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 6-7 years 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.