Director, Program Operations Leader- Hematology

Regeneron Pharmaceuticals; Basking Ridge (NJ); Hybrid; USD 202,000 - 337,000; Full time

Job summary

An established industry player is seeking a Program Operations Leader to drive the operational strategy for complex clinical programs. This role requires a seasoned professional with extensive experience in clinical trial management, capable of leading teams and managing budgets effectively. You will be at the forefront of clinical research, ensuring quality and compliance while navigating the complexities of clinical operations. Join a company that values diversity and offers comprehensive benefits, including health programs, fitness centers, and equity awards. If you're ready to make a significant impact in the field of clinical research, this opportunity is for you.

Benefits

Health and Wellness Programs

Fitness Centers

Equity Awards

Annual Bonuses

Paid Time Off

Qualifications

• 12+ years of sponsor-side industry experience, with 8 years in clinical trial management.
• Strong analytical and leadership skills with budget management expertise.

Responsibilities

• Lead clinical study teams and ensure project success within budget and timelines.
• Oversee clinical study operations and manage relationships with CROs and vendors.

Skills

Leadership Skills

Analytical Skills

Budget Management

Communication Skills

Problem Solving

Interpersonal 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.

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