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Director, Program Operations Leader - Internal Medicine

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  • Job
    Full-time
    Expert Level
  • Dublin

Requirements

  • - 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
  • - Bachelor's degree and minimum of 12 years relevant in-house sponsor-side pharmaceutical industry experience, 8 years within Clinical Trial Management
  • - Experience in Internal Medicine is highly preferred (obesity, metabolism, diabetes, cardiovascular)
  • - Experience in Phase 4 trials is highly preferred
  • - Previous people management experience required

Responsibilities

  • - Be responsible for the overall success of the clinical study team(s) within a program(s)
  • - Maintains 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 partners as requested
  • - Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
  • - Coordinates clinical study timelines within a clinical program(s)
  • - Provides input and operational insight into Clinical Study Concepts (CSC)
  • - Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
  • - Review of 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 standard processes within CTM
  • - Leads all aspects of 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

FAQs

What is the job title for this position?

The job title is Director, Program Operations Leader - Internal Medicine.

Where is the position located?

The position is hybrid and requires a minimum of 3 days on-site in Basking Ridge, NJ, Armonk, NY, Uxbridge, UK, or Dublin, IRE.

What are the main responsibilities of the Program Operations Leader?

The main responsibilities include leading and implementing the operational strategy for one or more complex programs in Clinical Trial Management, overseeing clinical operations activities, managing clinical trial management staff, and ensuring the success of clinical study teams.

What qualifications are required for this position?

Candidates must have a Bachelor's degree and a minimum of 12 years of relevant in-house sponsor-side pharmaceutical industry experience, with at least 8 years in Clinical Trial Management.

Is experience in Internal Medicine required?

Experience in Internal Medicine (specifically in areas like obesity, metabolism, diabetes, and cardiovascular) is highly preferred but not explicitly required.

What type of management experience is needed?

Previous people management experience is required for this position.

What skills are essential for candidates applying for this role?

Essential skills include advanced interpersonal and leadership skills, strong analytical abilities, budget management expertise, expert project management skills, and the ability to influence and negotiate across various senior partners.

What is the salary range for this position?

The salary range for this position is $198,000.00 - $330,000.00 annually.

Does Regeneron offer benefits to employees?

Yes, Regeneron provides comprehensive benefits, which may include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.

What is the company’s policy on equal opportunity employment?

Regeneron is an equal opportunity employer and considers all qualified applicants for employment without regard to various protected characteristics as per applicable laws and regulations.

Are background checks part of the recruitment process?

Yes, background checks will be conducted as part of the recruitment process in accordance with the laws of the country where the position is based.

Is this position focused on a specific phase of clinical trials?

Experience in Phase 4 trials is highly preferred for this position, although the role encompasses various phases of clinical trials.

Will the hired candidate need to report on the status of clinical programs?

Yes, the POL will be responsible for maintaining an overview of clinical program status and proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and budgets.

What key role does the Director POL play in financial management?

The Director POL leads all aspects of clinical study budgets within a program, ensuring the budget is reviewed, approved, and managed throughout the lifecycle of the program.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Regeneron is a leading biotechnology company that focuses on discovering, developing, and commercialising innovative medicines for serious medical conditions. Their work spans across various therapeutic areas, including oncology, ophthalmology, immunology, and infectious diseases. Regeneron's ultimate goal is to bring groundbreaking therapies to patients who need them, transforming the way diseases are treated and improving quality of life. The company is driven by a commitment to science, innovation, and the relentless pursuit of solutions to some of the most challenging health issues in the world today.