Director, Program Operations Leader - Oncology

Regeneron Pharmaceuticals, Inc; Armonk (NY); Hybrid; USD 202,000 - 337,000; Full time

Job summary

An established industry player is seeking a Director Program Operations Leader to spearhead complex clinical programs in oncology. This hybrid role involves strategic management, ensuring quality and compliance in clinical trial operations, and leading a dedicated team. You will play a crucial role in overseeing timelines, budgets, and vendor relations while driving innovative solutions to operational challenges. Join a dynamic and inclusive environment that values diverse perspectives and offers comprehensive benefits. If you are passionate about advancing clinical research and making a significant impact in the field of oncology, this is the perfect opportunity for you.

Qualifications

• 12+ years of industry experience with 8 years in clinical trial management.
• Oncology experience is required, especially with early-stage assets.

Responsibilities

• Lead clinical study teams to ensure success and timely delivery.
• Oversee budgets and communicate changes to stakeholders.
• Provide operational insights and manage vendor relationships.

Skills

Clinical Trial Management

Oncology

Project Management

Budget Management

Vendor Management

Risk Mitigation

Education

Bachelor's Degree

Job description

This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible.

The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management 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 Dir 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 Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.

In a typical day, you will:

1. Be responsible for the overall success of the clinical study team(s) within a program(s).
2. 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.
3. Provide operational insight into feasibility, timeline, and cost estimates during clinical program/study development.
4. Oversee clinical study timelines within a clinical program(s).
5. Provide input and operational insight into Clinical Study Concepts (CSC).
6. Review plans and provide 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.
7. 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 TA Operations Leader, as appropriate.
8. Ensure timely delivery of quality operational deliverables and be accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
9. Drive decision-making and integrate all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation.
10. Act as point of contact for clinical program and study level escalation.
11. Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress.
12. Provide proactive creation and implementation of risk mitigation strategies.
13. Provide innovative and flexible operational solutions and options to the cross-functional and development teams; assist in preparing scenarios for creative solutions to operational challenges.
14. Drive the strategy and oversight for vendor selection and management within a clinical program(s).
15. Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationships with key CRO (functional and project) and vendor counterparts.

To be considered, you must possess a Bachelor’s degree, and a minimum of 12 years relevant industry experience, with 8 years within clinical trial management. Oncology experience is required. Experience with early-stage oncology assets is highly preferred.

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.

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.

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.

Salary Range (annually): $202,000.00 - $336,600.00