BioSpace
Director, Precision Medicine, Companion Diagnostics
BioSpace, Armonk, New York, United States, 10504
Overview
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Director, Precision Medicine, Companion Diagnostics
role at
BioSpace
We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification, passionate about immunohistochemistry (IHC), 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 to support early and late-stage programs within our oncology pipeline.
Responsibilities
Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs
Develop strong relationships and 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 (including IVDR) and support regulatory teams surrounding CDx (from study setup to PMA filing). Have a solid understanding of Performance Study requirements and make strategic decisions and drive delivery in coordination with IVD regulatory counterparts
Be viewed as a subject matter expert in oncology and able to effectively communicate with clinical study teams on program direction
Able to define and drive CDx strategy and effectively gain alignment across relevant partners (including senior management) within Regeneron
Lead execution and implementation of Regeneron CDx strategy in collaboration with key partners
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
Qualifications 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. You demonstrate strong leadership skills with a high level of emotional intelligence and effectively work collaboratively with colleagues, vendors, and internally at Regeneron to ensure program success. Leads team members in representing Regeneron and working with colleagues from allied companies to develop and implement Precision Medicine CDx strategies.
To be considered for this role, you must have a Ph.D. and/or M.D. Minimum of 10 years postdoctoral experience in matrix interactions, preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams. Extensive experience in diagnostic development with demonstrated success in a drug development setting. We need a strong understanding of technical, regulatory, clinical, and strategic aspects of diagnostic delivery. We are seeking CDx knowledge, demonstrated deep knowledge in science and technology. Demonstrated experience in delivering diagnostics. Contributes to and reviews documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external meetings.
Salary Range (annually) : $198,000.00 - $330,000.00
Seniority level : Director
Employment type : Full-time
Job function : Other
Industries : Internet News
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, disability, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in the U.S., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, the salary ranges are shown in accordance with applicable local law and currency. If you are outside the U.S., Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Background checks may form part of the recruitment process in accordance with local law. This may include verification of identity, right to work, educational qualifications, and other information as required.
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Director, Precision Medicine, Companion Diagnostics
role at
BioSpace
We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification, passionate about immunohistochemistry (IHC), 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 to support early and late-stage programs within our oncology pipeline.
Responsibilities
Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs
Develop strong relationships and 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 (including IVDR) and support regulatory teams surrounding CDx (from study setup to PMA filing). Have a solid understanding of Performance Study requirements and make strategic decisions and drive delivery in coordination with IVD regulatory counterparts
Be viewed as a subject matter expert in oncology and able to effectively communicate with clinical study teams on program direction
Able to define and drive CDx strategy and effectively gain alignment across relevant partners (including senior management) within Regeneron
Lead execution and implementation of Regeneron CDx strategy in collaboration with key partners
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
Qualifications 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. You demonstrate strong leadership skills with a high level of emotional intelligence and effectively work collaboratively with colleagues, vendors, and internally at Regeneron to ensure program success. Leads team members in representing Regeneron and working with colleagues from allied companies to develop and implement Precision Medicine CDx strategies.
To be considered for this role, you must have a Ph.D. and/or M.D. Minimum of 10 years postdoctoral experience in matrix interactions, preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams. Extensive experience in diagnostic development with demonstrated success in a drug development setting. We need a strong understanding of technical, regulatory, clinical, and strategic aspects of diagnostic delivery. We are seeking CDx knowledge, demonstrated deep knowledge in science and technology. Demonstrated experience in delivering diagnostics. Contributes to and reviews documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external meetings.
Salary Range (annually) : $198,000.00 - $330,000.00
Seniority level : Director
Employment type : Full-time
Job function : Other
Industries : Internet News
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, disability, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in the U.S., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, the salary ranges are shown in accordance with applicable local law and currency. If you are outside the U.S., Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Background checks may form part of the recruitment process in accordance with local law. This may include verification of identity, right to work, educational qualifications, and other information as required.
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