BioSpace, Inc.
Senior Manager, Companion Diagnostics Operational Management
BioSpace, Inc., Basking Ridge, New Jersey, us, 07920
Job Details
The role of Senior Manager, Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD, etc.) within Regenerons drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, program/project management and operational execution of complex diagnostic strategies to support clinical programs across a variety of therapeutic indications. The successful candidate will work cross-functionally within Diagnostic team, Precision Medicine and other functions internally to anticipate and meet the needs of these programs as well as ensure seamless delivery to milestones. Additionally, this role will serve as a key point of contact with external diagnostic partners, laboratories and vendors required to support development and delivery of the diagnostic strategies.
As a Senior Manager, a typical day may include the following:
Portfolio Management and Leadership:Proactively manage assigned portfolio of diagnostic projects supporting Regenerons drug development programsWorking with the diagnostic team and key internal functions, establish and execute partnership and operational strategies to enable delivery of diagnostic projectsDevelop, build and implement processes and tools to support and the Diagnostics function to ensure quality, efficient and timely deliveryEffectively partner with external diagnostic manufacturers, laboratories and vendors to support delivery of diagnostic tools and strategies. Provide oversight and leadership of external relationships as neededDiagnostics Project Execution:
Drive the execution of the Dx/CDx strategy in parallel to the corresponding Regeneron clinical drug development programs and studies with close collaboration to CDx Strategy Leads, clinical laboratory managers, IVD regulatory and others as requiredTrack and lead project scope, costs, budget, contracts, timelines, risks and dependenciesReview clinical protocols, informed consent documents and other clinical trial deliverables and work with other key reviewers to ensure accuracy of diagnostic representationCoordinate laboratory specifications, builds and start up to ensure compliant assay is ready for clinical trial patient testingOversee critical samples, testing processes and quality; work with teams to resolve any related issues and escalate as neededClinical Drug Development Program and Study Team Involvement:
Serve as an active member of clinical study teams to ensure Dx/CDx planning is in line with clinical study plans and to ensure study teams are informed of Dx/CDx activities, status, budget and timelinesSupport Dx/CDx Strategy Lead and Dx/CDx management with information relevant to driving program strategy in participation with Strategic Program TeamsThis role may be for you if:
Strong collaboration and interpersonal skillsStrong communication and presentation skillsYou thrive in a cross functional team setting
To be considered for this role, you must have a BS/MS and a minimum of 7+ years of multi-disciplinary experience in biotech/pharmaceutical industry including diagnostic industry or CAP/CLIA laboratory setting. We are seeking a certificate in Project Management from an accredited university. Additionally, we need a minimum of 3+ years in a direct project/program management role. We need experience with project management tools to provide timelines and identify milestones. Understanding of GxP, CAP/CLIA, IVDR and applicable ISO regulations. We are seeking a strong understanding of laboratory practices, validation procedures and regulatory requirements. Proficient in business technology tools and understanding data (e.g. Microsoft Teams, Excel, PowerPoint, etc.).
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)$145,400.00 - $237,200.00
The role of Senior Manager, Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD, etc.) within Regenerons drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, program/project management and operational execution of complex diagnostic strategies to support clinical programs across a variety of therapeutic indications. The successful candidate will work cross-functionally within Diagnostic team, Precision Medicine and other functions internally to anticipate and meet the needs of these programs as well as ensure seamless delivery to milestones. Additionally, this role will serve as a key point of contact with external diagnostic partners, laboratories and vendors required to support development and delivery of the diagnostic strategies.
As a Senior Manager, a typical day may include the following:
Portfolio Management and Leadership:Proactively manage assigned portfolio of diagnostic projects supporting Regenerons drug development programsWorking with the diagnostic team and key internal functions, establish and execute partnership and operational strategies to enable delivery of diagnostic projectsDevelop, build and implement processes and tools to support and the Diagnostics function to ensure quality, efficient and timely deliveryEffectively partner with external diagnostic manufacturers, laboratories and vendors to support delivery of diagnostic tools and strategies. Provide oversight and leadership of external relationships as neededDiagnostics Project Execution:
Drive the execution of the Dx/CDx strategy in parallel to the corresponding Regeneron clinical drug development programs and studies with close collaboration to CDx Strategy Leads, clinical laboratory managers, IVD regulatory and others as requiredTrack and lead project scope, costs, budget, contracts, timelines, risks and dependenciesReview clinical protocols, informed consent documents and other clinical trial deliverables and work with other key reviewers to ensure accuracy of diagnostic representationCoordinate laboratory specifications, builds and start up to ensure compliant assay is ready for clinical trial patient testingOversee critical samples, testing processes and quality; work with teams to resolve any related issues and escalate as neededClinical Drug Development Program and Study Team Involvement:
Serve as an active member of clinical study teams to ensure Dx/CDx planning is in line with clinical study plans and to ensure study teams are informed of Dx/CDx activities, status, budget and timelinesSupport Dx/CDx Strategy Lead and Dx/CDx management with information relevant to driving program strategy in participation with Strategic Program TeamsThis role may be for you if:
Strong collaboration and interpersonal skillsStrong communication and presentation skillsYou thrive in a cross functional team setting
To be considered for this role, you must have a BS/MS and a minimum of 7+ years of multi-disciplinary experience in biotech/pharmaceutical industry including diagnostic industry or CAP/CLIA laboratory setting. We are seeking a certificate in Project Management from an accredited university. Additionally, we need a minimum of 3+ years in a direct project/program management role. We need experience with project management tools to provide timelines and identify milestones. Understanding of GxP, CAP/CLIA, IVDR and applicable ISO regulations. We are seeking a strong understanding of laboratory practices, validation procedures and regulatory requirements. Proficient in business technology tools and understanding data (e.g. Microsoft Teams, Excel, PowerPoint, etc.).
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)$145,400.00 - $237,200.00