The Senior Manager, Global Trial Optimization will lead program or study level activities advising on our clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. You will develop and maintain relationships with our external experts facilitating a wide source of country and disease area intelligence used in study design and operational planning.
A typical day may include the following:
• Lead study level feasibility processes to generate high quality and timely data to inform study design, efficient geographical placement and operational planning.
• Partner with teams during CRO led feasibility activities supporting validation of study and country level enrollment rates and study start up timelines to advise budget and baseline setting.
• Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management.
• Partner with Data and Analytics function to review and identify appropriate central data sources.
• Articulate the data story to teams based on country level feasibility and centrally derived data to support data driven decisions to improve protocol design
• Project management of study level country landscape assessment activities and the collection of targeted feasibility information for early assessment of operational feasibility for conducting clinical trials.
• Lead study level engagements to acquire, analyze and deliver high quality targeted information from external partners.
• Prove input into continuous improvement activities to ensure consistency of process execution.
• In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors.
• Develop and implement patient recruitment and retention tactics aligned with defined study strategy.
• Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
• May require up to 20% travel
To be considered a Bachelors degree in a related field with a minimum of 8 years of relevant industry experience within pharma/biotech, a CRO or consulting is required. Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval. Experience with feasibility. Must be a compelling communicator with ability to translate sophisticated messages to a variety of audiences.
Additional requirements include:
• Experience in using data to inform clinical strategy development
• Ability to understand sophisticated business questions and develop effective solutions
• Experience in process development, implementation and change management activities
• Line management experience preferred
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.
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