Manager, Internal Medicine, Clinical Scientist (Immune/Inflammatory)

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 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 considerat