Senior Manager, Global Trial Optimization

The Senior Manager, Global Trial Optimization (GTO) will lead program or study level activities to inform the clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. They will play a key role in developing and maintaining relationships with external experts to facilitate a wide source of country and disease area intelligence that can be utilized in study design and operational planning.

A typical day in this role looks like:

• Lead study level feasibility processes to generate high quality and timely data to inform study design, optimal geographical placement and operational planning.
• Partner with teams during CRO led feasibility activities to support validation of study and country level enrolment rates and study start up timelines to inform budget and baseline setting. * Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management activities.
• Partner with Data and Analytics function to review and identify appropriate central data sources and work with study teams to define assumptions for data curation and insight development
• Articulate the data story to teams based on based on country level feasibility and centrally derived data to support data driven decisions to enhance protocol design
• Project management of study level country landscape assessment activities and the collection of targeted feasibility information to support early assessment of operational feasibility for conducting clinical trials.
• Lead study level engagements to obtain, analyze and deliver high quality targeted information from external stakeholders to inform study design and operational planning decisions.
• Lead study level activities to generate and deliver patient level insights as required to teams to inform study design and operational planning.
• Prove input into a range of continuous improvement activities to ensure consistency of Global Trial Optimization process execution.
• In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors utilized in Global Trial Optimization processes
• Partner with study teams to develop and implement patient recruitment and retention tactics aligned with defined study strategy.

This role may be for you if have:

• Exceptional interpersonal & leadership skills
• Applied advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
• Can demonstrate expert knowledge and a data driven approach to planning, executing, and problem solving
• Advanced communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• The ability to influence and negotiate across a wide range of collaborators
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Advanced project management skills, cross-functional team leadership and organizational skills

In order to be considered qualified for this role a minimum of a Bachelors' degree and 8+ years of relevant industry experience .Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.

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.-based 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)

$129,800.00 - $211,800.00 Apply