Senior Manager, Clinical Scientist, Ophthalmology

Senior Manager, Clinical Scientist, Ophthalmology at Regeneron

The Senior Manager, Clinical Scientist, Ophthalmology at Regeneron leads in the development, evaluation, planning, and execution of clinical studies, ensuring the integrity and interpretation of study data within a clinical development program. This role operates in a matrix environment as part of a cross-functional team, contributing to candidate development projects across early and/or late phase development. Reporting to the Associate Director/Director, Clinical Sciences, the Senior Manager collaborates closely with Medical Director(s) to provide essential scientific expertise for designing and delivering clinical studies and programs.

As a Senior Manager, Clinical Scientist, Ophthalmology, your typical day may involve:

• Contributing to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings.
• Participating in collaborative activities with other departments and serving as a member of the Clinical Study Team and Global Clinical SubTeam.
• Developing and maintaining a deep understanding of therapeutic disease areas and drug candidates, including underlying disease biology, clinical manifestations, therapeutic standard practices, and the competitive drug landscape.
• Applying basic scientific expertise to support the initiation and execution of clinical research and development studies for early and/or late-stage assets.
• Assisting with the development of Expanded Synopses and authoring clinically relevant sections while reviewing other scientific portions of clinical trial protocols and amendments.
• Assisting with and potentially authoring/reviewing trial-related documents such as medical monitoring plans, Statistical Analysis Plans (SAPs), informed consents, and clinical components of Clinical Study Reports; may perform quality review.
• Maintaining compliance 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 that ensure patient safety.
• Collaborating with internal functions and external vendors to promote clinical study integrity.
• Exhibiting strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supporting the identification and/or identifying critical risks and mitigations.
• Promoting consistent first-line medical/clinical data review techniques and conventions across assigned studies; reviewing clinical data review plans and medical monitoring plans for assigned studies.

What You'll Bring to Regeneron

This role may be for you if you possess:

• Demonstrated ability to influence within your team and cross-functionally.
• Strong analytical and influencing skills, with the ability to communicate concise and clear messages and deliver strong presentations.
• The capability to independently use professional concepts and company objectives to resolve complex issues creatively and effectively.
• Strong management, interpersonal, and problem-solving skills.
• Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology, and medical writing skills.
• Knowledge of clinical development processes, regulatory requirements, and ICH/GCP guidelines, with a proven track record in clinical trial process improvements.
• Considerable organizational awareness, including significant experience working cross-functionally.

Qualifications

To be considered for this role, you must have a BS/MS/PhD/PharmD in a related field, along with a minimum of 8 years of pharmaceutical clinical drug development experience. Other experience levels may be considered. Experience in Ophthalmology clinical trials is specifically sought.

Regeneron Benefits

Regeneron offers an inclusive culture with comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (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.

Work Arrangement

At Regeneron, many roles are required to be performed on-site. Please discuss the on-site policy and expectations for your specific role and location with your recruiter and hiring manager.

Equal Opportunity Employer

Regeneron is an equal opportunity employer committed to diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, national or ethnic origin, civil status, age, citizenship status, sexual orientation, disability, genetic information, marital status, pregnancy, gender identity, military status, or any other protected characteristic. Reasonable accommodation will be provided for known disabilities or chronic illnesses unless it imposes undue hardship.

Salary & Background Checks

For U.S.-based roles, the salary range is $150,500.00 - $245,500.00 annually. Background checks will be conducted in accordance with the law of the country where the position is based to verify identity, right to work, and educational qualifications, among other information.

Key skills/competency

• Clinical Study Leadership
• Ophthalmology Research
• Clinical Data Interpretation
• Regulatory Compliance (ICH/GCP)
• Drug Development Process
• Cross-functional Collaboration
• Scientific Expertise
• Medical Monitoring
• Study Design Methodology
• Project Risk Mitigation