Director, Program Operations Leader- Hematology

Regeneron Pharmaceuticals, Inc; Village of Tarrytown, Basking Ridge, Armonk (NY, NJ, NY); Hybrid; USD 202,000 - 337,000; Full time

Job summary

An established industry player is seeking a Program Operations Leader to spearhead clinical trial management. This pivotal role involves leading operational strategies for complex clinical programs, ensuring quality, timelines, and budgets are met. You will collaborate with senior management and external partners, driving the success of clinical study teams. This position promises a dynamic work environment where your leadership and strategic insights will make a significant impact. With a commitment to diversity and inclusion, the company offers a range of benefits, making it a great place to advance your career in clinical operations.

Benefits

Health and Wellness Programs

Fitness Centers

Equity Awards

Annual Bonuses

Paid Time Off

Qualifications

• 12+ years of relevant sponsor-side industry experience.
• 8+ years in clinical trial management with leadership roles.

Responsibilities

• Lead operational strategy for complex clinical programs.
• Manage clinical trial budgets and timelines effectively.
• Oversee clinical study teams and ensure quality deliverables.

Skills

Interpersonal Skills

Leadership Skills

Analytical Skills

Budget Management Expertise

Communication Skills

Negotiation Skills

Technical Knowledge

Education

Bachelor's Degree

Job description

This role is on-site 4 days per week and 1 day from home. A fully remote role is not possible for this position.

The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is 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 and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility 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 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 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: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
• Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
• Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
• Acts as point of contact for clinical program and study level escalation
• Manages 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

To be considered for this role you must possess:

• 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 (i.e., functional area heads)
• Budget management expertise and strong financial acumen
• Significant line management experience with demonstrated mentoring and coaching skills
• Extensive experience in global clinical trial operations
• A working knowledge of GCP and ICH

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 Company's 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)

$202,000.00 - $336,600.00