We are seeking a Senior Manager, Clinical Sciences to lead in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. We hope you are excited to lead a matrix environment as part of a cross-functional team and contribute to projects through early and/or late phase development.
As a Senior Manager within Clinical Sciences, a typical day may include the following:
Contributing to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments
Developing and maintaining an understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
Applying basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late stage assets; assisting with development of the Expanded Synopsis and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments
Assisting with and may author/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support the development of regulatory documents; may perform quality review
Maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
Performing clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Identifying critical risks/mitigations and exhibiting strong analytical knowledge and skills to understand how study objectives and design impact data analysis
Promoting consistent first line medical/clinical data review techniques and conventions across assigned studies; Reviewing clinical data review plan and medical monitoring plan for assigned studies
This role may be for you if you: Have a demonstrated ability to influence and share new insights with study team
Ensure scientific integrity and interpretation of study data within a clinical development program
Can independently identify complex problems/out-of-policy issues and provide resolution using excellent problem-solving skills
Have strong management experience
To be considered for this role, you must have at least a BA/BS and 8+ years of pharmaceutical clinical drug development experience. Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We need someone with a shown knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines required. Must have considerable organizational awareness, including significant experience working cross-functionally.
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)
$145,400.00 - $237,200.00