Job Description
The Executive Director TA Operations Leader is responsible for leading the overall strategic management of one or more therapeutic areas in Clinical Trial Management (CTM). They direct clinical operations activities and decisions, ensuring quality, timelines, and costs are in line with applicable regulations, ICH/GCP guidelines, and company Standard Operating Procedures (SOPs) within assigned TAs.
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The role involves partnering with senior level management across the TA and functions to enable efficient delivery of assigned tasks. This includes sponsorship, leadership, and direction for departmental initiatives, as well as line management of staff, including recruitment, retention, professional development, and performance management.
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Key responsibilities include:
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1. Partnering with the Therapeutic Area Head and Global Program Heads to review TA progress and project status
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2. Ensuring delivery of quality operational deliverables while maintaining consistency of process and approaches across clinical programs within and across TAs
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3. Identifying and implementing opportunities for innovation within clinical trial operations
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4. Liaising closely with the Therapeutic Area Head, Development Portfolio Management, and Strategic Program Direction to ensure clinical study deliverables support clinical program goals and project execution
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Required Skills and Qualifications
To be considered for this role, you must have a Bachelor's degree, an advanced degree is highly desirable. You should have 15+ years of clinical operations experience in a pharmaceutical or biotech setting, with 10+ years of functional leadership, 10+ years of people management, leadership, and mentoring experience, and 5+ years of leading complex, global clinical trials with outsourced CRO/FSP models.
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You should also possess expertise in obesity, muscle, and metabolism, as well as in-depth knowledge of GCP and ICH, drug development processes, and other relevant guidelines for clinical research activities.
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Exceptional project management, cross-functional team leadership, and organizational skills are essential, as is the ability to make decisions, set priorities, and share resources based on an enterprise mindset.
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Ability to leverage networks to understand the big picture, perspectives, and expertise to maximize performance is also required.
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Benefits
Regeneron offers 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.
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The Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.
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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 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. positions.
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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.
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Background checks will form part of the recruitment process, conducted in accordance with the law of the country where the position is based.
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