Director, Program Operations Leader, Early Clinical Trial Development

2 days ago

Dublin, Dublin City, Ireland Regeneron Ireland Dac Full time

This role is a hybrid position which requires a minimum of 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 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 a 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 the 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.
Ability to apply 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, with the 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 a minimum of 12 years relevant pharmaceutical industry experience, with 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, 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. 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)

$198, $330,000.00 #J-18808-Ljbffr

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