Director, Precision Medicine Strategy Lead, Cell Medicines

We are seeking to hire a Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for Regeneron Cell Medicines involving novel cell therapies and combinations with bispecific antibodies across multiple disease areas.

In this highly matrixed role, they will design, develop, communicate across levels and operationally implement clinical biomarker strategies to support select programs in early and late stage drug development.

Clinical biomarker assays include pharmacokinetic assays, patient stratification assays as well as immunology based pharmacodynamic assays.

The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.

As a Director, a typical day may include the following :

• Program-level Precision Medicine lead for implementation of strategic vision for Pharmacokinetic and exploratory biomarkers in the clinic to enable indication and / or patient selection, early indication of biological activity and potential novel combinations.
• Collaborate with Biomarker and clinical operation teams to implement specific biomarker and exploratory sample collection and analyses in all relevant clinical studies in selected programs.
• Key individual contributor and precision medicine representative to development and Cell therapy characterization teams with a remit to integrate, influence and deliver biomarker strategies from initial concept to execution, data delivery and results interpretation.
• Collaborate with internal Regeneron laboratories and groups (e.g. BioAnalytical, Clinical Pharmacology, Molecular Profiling, CDX, Discovery Research, Analytical Innovations, DMSQ etc.

to develop plan for validation and application of assays in the clinic.

• Accountability for ensuring complex clinical assays used in programs are fit-for-purpose (whether developed and validated internally or externally).
• Collaborate with Discovery Research and product development teams to facilitate appropriate incorporation of Precision Medicine biomarker strategies for molecules in discovery phases (leading to candidate molecule selection) through to the clinic.
• Represent Regeneron externally through allied corporate, academic clinical and research partnerships.
• Contribute to Clinical Protocol, schedule of Assessments, clinical study reports, technical reports, data agreements, scientific publications and make recommendations to development teams and management.

This role may be for you if :

• The ability to drive, manage, complete and deliver results for complex multi-functional projects.
• Excellent communication and presentation skills and high emotional intelligence, organizational skills and effective team skills.

To be considered for this role, you must have a PhD and 10+ years of experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry.

Experience in clinical assay development, validation and implementation with strong experience in Immunology is preferred.

Regeneron Cell Medicines (RCM) has been created to advance the next generation of cell therapies and explore combinations with Regeneron’s proprietary antibodies and bispecifics.

We are a group of about 160 research, development, manufacturing and clinical employees based in Seattle, WA and Cambridge, MA.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, 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 which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.

S. law and apply to U.S.-based positions. For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the 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.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually) $198,000.00 - $330,000.00

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