Associate Director, Precision Medicine - Diagnostics Project Management & Delivery
New Today
In this role, a typical day might include:
The role of Associate Director, Diagnostics Project Management & Delivery, is expected to manage and deliver the execution of diagnostic projects (CDx, IVD, etc.) within Regeneron's drug development pipeline in partnership with Diagnostic Strategy Leads and IVD Regulatory Affairs. This is a leadership role within Regeneron's clinical diagnostics team to provide portfolio management, program/project management, strategic input and execution of complex diagnostic strategies to support clinical programs across multiple therapeutic areas. The successful candidate will lead and partner cross-functionally within the Diagnostics team, Precision Medicine Strategy, Laboratory Operations, to directly lead and/or lead resources with and without authority. The role will contribute to building a framework to ensure effective planning and handoff from diagnostic strategy to execution phase with both internal and external resources serving as a key point of contact with internal clinical teams, external diagnostic partners, laboratories and vendors. The candidate must have strong expertise in drug development planning and CDx/IVD development with pharmaceutical companies.
This role might be for you if you can:
Project Management and People Leadership:
- Proactively plan, manage and execute assigned portfolio of diagnostic projects supporting Regeneron's drug development programs
- Continuously review Regeneron's drug development pipeline and portfolio, build relationships with key stakeholders in clinical development units and other functions, and facilitate diagnostic assessments to ensure the Dx team is supporting all relevant clinical programs
- Leverage tools and other resources to maintain portfolio and project level information to track timelines/deliverables and communicate effectively to cross-functional stakeholders
- Develop, build and implement processes and tools to support and the Diagnostics function to ensure quality, efficient and timely delivery
- Effectively partner with external diagnostic manufacturers, laboratories and vendors to support delivery of diagnostic tools and strategies. Provide oversight and leadership of external relationships as needed
- Represent Diagnostics team as an expert and leader to drive knowledge of diagnostic delivery, learning, regulatory impacts and operational considerations
Diagnostics Project Execution:
- Working with the Diagnostic Strategy Lead, define the diagnostic delivery plan and serve as the main point of contact internally and externally for the duration of the diagnostic project
- Identify, communicate and manage risks to the strategy and delivery plan
- Develop, align and oversee execution of diagnostic development, operational and commercial plans
- Manage (with and without authority) a team of resources contributing to delivery of the diagnostic strategy
- Communicate effectively with stakeholders to resolve quality issues and ensure continuous improvement internally and with our Dx partners and labs
- Develop and maintain project plans to closely track CDx development and CDx regulatory activities against clinical drug development and study timelines
- Review clinical protocols, informed consent documents and other clinical trial deliverables and work with other key reviewers to ensure accuracy of diagnostic language
- Demonstrate high acumen regarding drug development, assay development and laboratory build, quality and execution for use of IVDs and CDx in clinical trials
- Oversee requirements for laboratory specifications, builds and start up activities to ensure diagnostic assay is ready for clinical trial patient testing
- Lead oversight of critical samples, testing processes and quality; work with teams to resolve any related issues and escalate as needed
Clinical 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 timelines
- Support Dx/CDx Strategy Lead and Dx/CDx management with information relevant to driving program strategy in participation with Strategic Program Teams
- Stakeholder Management & External Collaborations
- Manage and integrate with team members from functional groups across Regeneron using data driven approaches
- Partner with laboratory operations team to align on biomarker testing and sample oversight activities
- Work closely with external diagnostic partners, central laboratories and specialty testing labs
To be considered for this opportunity, you must have the following:
- Minimum of 8+ years of experience in biotech/pharmaceutical industry and/or diagnostic industry with strong knowledge of GCP, CAP/CLIA, US FDA and IVDR laboratory and diagnostic requirements
- Bachelor's degree in sciences required, advanced degree or PhD preferred
- Demonstrated experience in clinical trial and diagnostic development planning and project management
- Experience with project management tools to provide timelines and identify milestones
- Strong organization, collaboration, communication and presentation skills
- Excellent at thinking and working on the fly and under pressure, problem solving and providing consultative approaches
- Experience working with cross-functional clinical study teams
- Understanding of GxP, CAP/CLIA, FDA, PMDA, IVDR and applicable ISO regulations
- Strong understanding of laboratory practices, validation procedures and regulatory requirements
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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)
$173,500.00 - $283,100.00
- Location:
- Tarrytown