Director, Program Operations Leader - Early Phase Clinical Trials
Director, Program Operations Leader - Early Phase Clinical Trials
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Job Description
For US Locations this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position.
The Director Program Operations Leader (POL) is responsible for leadership and overallstrategic management of one or more complex programs in Clinical Trial Management (CTM). This individualis responsible for clinical operations activities and decisions including quality timelines and budgets related to
the conduct of clinical research studies in accordance with applicable regulations ICH/GCP regulations andcompany Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the
Clinical Trial Management extended leadership team and as such interacts with senior level managementexternal vendors collaboration partners and clinical study personnel for clinical research project and department
initiatives. The Dir POL is responsible for line management of clinical trial management staff includingresponsibility for staff recruitment development coaching mentoring and performance management.
In a typical day you will:
Be responsible for the overall success of the clinical study team(s) within a program(s)
Maintain an overview of clinical program(s) status and issues and proactively communicates progressrisks issues or changes that may impact quality timelines and/or budget; provide clinical program level
updates to stakeholders as requested
Provide operational insight into feasibility timeline and cost estimates during clinical program/studydevelopment
Oversee clinical study timelines within a clinical program(s)
Provide input and operational insight into Clinical Study Concepts (CSC)
Review of plans and provision of clinical operations expertise during protocol design feasibility studystart up and conduct phases of studies. Ensure consistency within the program and development of best
practices within CTM
Oversee clinical study budgets within a program: ensures review presentation and approval of initial
study budget and manages the budget through the lifecycle of the program by communicating changes toTA Operations Leader as appropriate
Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency ofprocess and approaches across clinical study teams within the clinical program(s).
Drives decision making and integrates all operational considerations for studies within a clinicalprogram(s) to ensure goals are attainable prior to implementation
Be responsible for direct supervision of CTM staff. Line management responsibilities include: workassignments performance management staff recruitment professional development coachingmentoring ongoing training and compliance and study support/oversight.
To be considered you must possess:
A Bachelors degree and minimum of 12 years relevant in-house sponsor-side industry experience 8 years within clinical operations.
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 Companys 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)
Required Experience:
Director
Employment Type
Full-Time
