Manager, Clinical Scientist, Internal Medicine (Cardio, Metabolic, & Renal)

Regeneron Pharmaceuticals•Village of Tarrytown, NY

2d•Onsite

About The Position

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 one or more of the following therapeutic areas is preferred – cardiovascular, renal, metabolic disease. Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. (1 of 2) 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. Salary Range (annually) $128,600.00 - $210,000.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Requirements

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
BS/MS/PhD/PharmD in a related area
≥ 6 years of pharmaceutical clinical drug development experience
Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines

Nice To Haves

experience in one or more of the following therapeutic areas is preferred – cardiovascular, renal, metabolic disease

Responsibilities

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

Benefits

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
paid leaves (e.g., military and parental leave)

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