BioSpace
Director, Program Operations Leader - Early Phase Clinical Trials
BioSpace, Trenton, New Jersey, United States
Director, Program Operations Leader - Early Phase Clinical Trials
Join to apply for the Director, Program Operations Leader - Early Phase Clinical Trials role at BioSpace.
For U.S. 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.
Responsibilities
Be responsible for the overall success of the clinical study team(s) within 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)
Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start‑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: ensure review, presentation and approval of initial study budget and manage the budget through the lifecycle of the program by communicating changes to the TA Operations Leader, as appropriate
Ensure timely delivery of quality operational deliverables and be accountable for 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
Be responsible for direct supervision of CTM staff. Line‑management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training, compliance, and study support/oversight.
Qualifications
A bachelor's degree and minimum of 12 years relevant in‑house sponsor‑side industry experience, 8 years within clinical operations.
Salary Range (annually): $0.00 - $0.00.
Equal Employment Opportunity 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.
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For U.S. 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.
Responsibilities
Be responsible for the overall success of the clinical study team(s) within 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)
Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start‑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: ensure review, presentation and approval of initial study budget and manage the budget through the lifecycle of the program by communicating changes to the TA Operations Leader, as appropriate
Ensure timely delivery of quality operational deliverables and be accountable for 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
Be responsible for direct supervision of CTM staff. Line‑management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training, compliance, and study support/oversight.
Qualifications
A bachelor's degree and minimum of 12 years relevant in‑house sponsor‑side industry experience, 8 years within clinical operations.
Salary Range (annually): $0.00 - $0.00.
Equal Employment Opportunity 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.
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