About the role

Aplyr's Quick Take

This role is for a Manager in Clinical Science focused on overseeing and supporting clinical studies in immune and inflammatory diseases. You'll work in a team, collaborating with various departments to ensure studies are scientifically sound and compliant with regulations. It's a mix of project management and scientific input, rather than a purely research or administrative role.

Good fit

Ideal candidates have a background in clinical research or a related scientific field, with some experience in managing projects or teams. You should be comfortable in a collaborative environment and have a solid understanding of clinical trial processes.

Worth noting

The salary range is quite high, suggesting they may be looking for experienced professionals. The role requires a balance of scientific knowledge and project management skills, which may not suit everyone.

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

Aplyr's read

Regeneron Pharmaceuticals is a biotechnology leader focused on innovative medicines for serious diseases, attracting talent in scientific, regulatory, and commercial roles.
Synthesized from recent postings & public sources

What's promising

•Regeneron is at the forefront of biotechnology with a strong pipeline of innovative medicines.
•The company offers diverse roles across scientific, regulatory, and commercial functions, indicating robust growth.
•Regeneron's commitment to R&D is evident in its substantial investment in cutting-edge technologies.

What to watch

•The competitive biotechnology field requires constant innovation, posing sustainability challenges.
•Regeneron's success heavily depends on regulatory approvals, which can be unpredictable.
•The company faces significant competition from other biotech firms in drug development.

Why Regeneron

•Regeneron has a distinctive focus on antibody-based medicines, setting it apart in the biotech industry.
•The company is renowned for its proprietary VelociSuite technologies, enhancing drug discovery.
•Regeneron's collaborative culture fosters innovation and cross-disciplinary teamwork in drug development.

Aplyr’s read is generated by AI from public sources. Was it useful?