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Village of Tarrytown, New York, United States
Onsite
Available
We are seeking a Manager, Clinical Scientist to join our team. The Manager Clinical Scientist assists 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 Manager works in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Manager reports to the Associate Director/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.
As a Manager within Clinical Sciences, a typical day may include the following:
Member of the Clinical Study Team and the Global Clinical SubTeam; regularly attends and actively participates in study team meetings
May contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments
Develops/maintains basic 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 limited knowledge of disease and drug landscape
Applies basic scientific expertise to support execution of clinical research and development studies for early and/or late stage assets
May assist with preparation of documents related to trials, such as medical monitoring plans, SAPs, informed consents, clinical components of the Clinical Study Reports and regulatory documents; collaborate with others for scientific and foundational guidance
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
May contribute to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority)
Supports clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Supports identification of data trends and potential inconsistencies in data across assigned studies and raises
Exhibits basic research and analytical knowledge to understand how study objectives and design impact data analysis; supports identification of critical risks and mitigations to study
This role may be for you if:
Demonstrated basic knowledge of the drug development process, Good Clinical Practice, study design and clinical research methodology; beginner level medical writing skills
Demonstrate some ability to influence within study team
Independently resolves most issues and complex matters, requiring advanced analytical skill, training and/or education. Raises highly complex problems or out-of-policy issues
Strong management, interpersonal and problem-solving skills
Proven track record in clinical trial process improvements
Considerable organizational awareness, including significant experience working cross-functionally
To be considered for this role, you must have a BS/MS/PhD/PharmD in a related area. Additionally, ≥ 6 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. We are seeking experience in immune/inflammatory related clinical trials. Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$128,600.00 - $210,000.00