Director, Program Operations Leader, Early Clinical Trial Development

Regeneron Pharmaceuticals; Basking Ridge (NJ); Hybrid; USD 198,000 - 330,000; Full time

Job summary

An established industry player is seeking a Program Operations Leader to spearhead the operational strategy for complex clinical programs. This hybrid role demands strong leadership and analytical skills, as you will oversee clinical operations activities and ensure compliance with industry regulations. You'll collaborate with senior management and external partners while managing budgets and timelines for clinical studies. If you are proactive, self-disciplined, and thrive in a dynamic environment, this opportunity offers a chance to make a significant impact in clinical research while being part of a diverse and inclusive culture.

Benefits

Comprehensive Benefits

Inclusive Culture

Diverse Work Environment

Qualifications

• Minimum 12 years in the pharmaceutical industry with 8 years in Clinical Trial Management.
• Experience with early phase clinical trials is highly preferred.

Responsibilities

• Lead operational strategy for complex clinical programs in Clinical Trial Management.
• Manage clinical study budgets and timelines, ensuring quality and compliance.

Skills

Interpersonal Skills

Leadership Skills

Analytical Skills

Budget Management

Project Management

Communication Skills

Negotiation Skills

Education

Bachelor's Degree

Job description

This role is a hybrid position which requires a minimum 3 days on-site in Basking Ridge, NJ or Armonk, NY. Remote work is not an option for this role.

The Program Operations Leader (POL) will lead and implement 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. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence.

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 communicate progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to partners as requested.
• Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development.
• Coordinate 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 provide clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of standard processes within CTM.
• Lead all aspects of 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.

This job may be for you if you have:

• Advanced interpersonal & leadership skills.
• Ability to provide operational strategic direction and guidance for clinical programs.
• Applies sophisticated 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 interpersonal skills via verbal, written and presentation abilities.
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization.
• Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads).
• Budget management expertise and strong financial competence.
• Consistent track record of building, leading and developing productive teams and collaborations.
• Expert project management skills, cross-functional engagement and organizational skills.

To be considered, you must have a Bachelor's degree and minimum of 12 years relevant pharmaceutical industry experience, 8 years within Clinical Trial Management. Experience with early phase clinical trials 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.

Salary Range (annually)
$198,000.00 - $330,000.00