Job Title:
Director, Program Operations Leader
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Job Summary:
This position offers a unique opportunity to lead the operational strategy for delivery of complex programs in Clinical Trial Management (CTM). As a key member of the Clinical Trial Management extended leadership team, you will interact with senior level management, external vendors, collaboration partners, and clinical study personnel for clinical research project and department initiatives.
In this role, you will be responsible for the overall success of the clinical study team(s) within a program(s), maintaining an overview of clinical program(s) status and issues, and proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and/or budget.
* Main Responsibilities:
* Develop and implement operational strategy, driving early study planning, budget, and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start-up, and conduct phases of studies
* Provide operational insight into feasibility, timeline, and cost estimates during clinical program/study development
* 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
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Required Skills and Qualifications:
* Bachelor's degree and minimum of 12 years relevant sponsor-side industry experience, 8 years within clinical trial management
* Advanced interpersonal & leadership skills
* Ability to provide operational strategic direction and guidance for clinical programs
* Advanced technical knowledge to solve highly complex issues
* An understanding of relevant industry trends
* Strong analytical skills with a data-driven approach to planning, executing, and problem-solving
* Advanced communication skills via verbal, written, and presentation abilities
* Ability to influence and negotiate across a wide range of senior stakeholders
* Significant line management experience with demonstrated mentoring and coaching skills
* Extensive experience in global clinical trial operations
* A working knowledge of GCP and ICH
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Benefits:
We have an inclusive and diverse culture that provides comprehensive benefits, which often include 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. We welcome applications from qualified candidates regardless of their 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.
We are committed to making reasonable accommodations 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 our business.