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Director, Program Operations Leader - Ophthalmology/Renal
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- Ireland
- Ireland
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Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.
Program Operations Leader (POL) leads operational strategy for delivery of complex clinical trial programs, ensuring compliance with regulations, quality, timelines, and budgets.
Key Responsibilities
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 communicate progress, risks, 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/study development
Oversee clinical study timelines within a clinical program(s)
Provide input and operational insight into Clinical Study Concepts (CSC)
Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
Review plans and provide clinical operations expertise during protocol design, feasibility, study start‑up and conduct phases of studies. Ensure consistency within the program and develop best practices within CTM
Oversee clinical study budgets within a program: ensure review, presentation and approval of initial study budget and manage the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
Ensure timely delivery of quality operational deliverables and be accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)
Drive decision making and integrate all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
Act as point of contact for clinical program and study level escalation
Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
Provide proactive creation and implementation of risk mitigation strategies
Provide innovative and flexible operational solutions and options to the cross‑functional and development teams; assist in preparing scenarios for creative solutions to operational challenges
Drive the strategy and oversight for vendor selection and management within a clinical program(s)
Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
May require up to 25% travel
Qualifications
Minimum requirements: Bachelor’s degree and at least 12 years of sponsor‑side pharmaceutical experience, including 8 years in clinical operations.
Compensation
Salary Range (annually) : $205,000.00 - $341,600.00.
Equal Opportunity Employment
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. xcfaprz 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.
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Sprachkenntnisse
- English
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