Temp Senior Manager, Clinical Sciences 

Pay Range: $80 - $100/hr

Remote Role (US Only)

12 Month Contract

Regeneron is 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.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation