Regeneron Pharmaceuticals, Inc
Associate Director, Precision Medicine Clinical Laboratory Operations
Regeneron Pharmaceuticals, Inc, New York, New York, us, 10261
The Associate Director, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to provide strategic oversight of laboratory deliverables across the portfolio, ensuring that study start timelines are met, and provide risk management. Collaborates with stakeholders for all aspects of clinical laboratory deliverables (from study conduct, sample management testing to launch). This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.As an Associate Director, a typical day may include the following:Perform strategic and clinical laboratory portfolio management for Regeneron clinical trials and review clinical laboratory operations timelines and risks and be able to manage and communicate risks and ensure study starts and data delivery are aligned with expectations.
Be a subject matter expert on central and specialty laboratory processes and leverage this knowledge to be a trusted collaborator and ensure clinical laboratory deliverables.
Work closely with collaborators to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies, identifying and tracking risks and decisions, creating mitigation plans.
Inform and shape clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines.
Develop strong relationships and trust with internal and cross-functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads, and others within Global Development to manage and implement program level clinical laboratory management.
Demonstrate relevant knowledge and understanding of clinical laboratory trial requirements on the program and implement strategic operational decisions. Ensure the laboratory portion of the studies are harmonized for assigned program from onset to final delivery.
Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction. Demonstrate authority for the studies related to the program. Establish as a leader for the program and can dive into the details when required, with attention to detail.
Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment, design and develop processes to address identified gaps.
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 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 Bachelor's degree, a minimum of 10 years of pharmaceutical experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams. A minimum of 5 years’ experience with Clinical Trials, focusing on clinical sample collection is required. Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience is requested. A strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery is required. We are seeking clinical study knowledge, demonstrated by knowledge in science and technology. Demonstrated experience in stakeholder management, leading internal and external meetings and solutioning skills is essential.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)$151,800.00 - $247,800.00
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Be a subject matter expert on central and specialty laboratory processes and leverage this knowledge to be a trusted collaborator and ensure clinical laboratory deliverables.
Work closely with collaborators to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies, identifying and tracking risks and decisions, creating mitigation plans.
Inform and shape clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines.
Develop strong relationships and trust with internal and cross-functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads, and others within Global Development to manage and implement program level clinical laboratory management.
Demonstrate relevant knowledge and understanding of clinical laboratory trial requirements on the program and implement strategic operational decisions. Ensure the laboratory portion of the studies are harmonized for assigned program from onset to final delivery.
Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction. Demonstrate authority for the studies related to the program. Establish as a leader for the program and can dive into the details when required, with attention to detail.
Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment, design and develop processes to address identified gaps.
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 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 Bachelor's degree, a minimum of 10 years of pharmaceutical experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams. A minimum of 5 years’ experience with Clinical Trials, focusing on clinical sample collection is required. Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience is requested. A strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery is required. We are seeking clinical study knowledge, demonstrated by knowledge in science and technology. Demonstrated experience in stakeholder management, leading internal and external meetings and solutioning skills is essential.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)$151,800.00 - $247,800.00
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