Associate Director, Clinical Scientist, Ophthalmology

Regeneron; Village of Tarrytown (NY); Hybrid; USD 176,100 - 287,300; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health and wellness programs

Job summary

Regeneron is seeking an Associate Director to join the Clinical Scientist team in Tarrytown, NY. In this hybrid role, you will lead the development and execution of clinical studies, utilizing your expertise in the pharmaceutical drug development process.

The ideal candidate has a strong background in Ophthalmology, at least 10 years of experience, and excellent medical writing skills. You will play a critical role in ensuring scientific integrity and collaborating with cross-functional teams to deliver impactful clinical programs.

Qualifications

• 10+ years of pharmaceutical clinical drug development experience, preferably in Ophthalmology.
• Strong ability to influence across functions and act as a team player.
• Proficient knowledge of Good Clinical Practice and study design.

Responsibilities

• Conception and execution of clinical research and development studies.
• Development and review of clinical trial protocols and amendments.
• Planning and preparation for stakeholder meetings and presentations.

Skills

Pharmaceutical clinical drug development

Ophthalmology knowledge

Clinical research methodology

Medical writing skills

Cross-functional management

Education

Bachelor's Degree

Advanced degree (PhD/PharmD/MSc)

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking an Associate Director to join our Clinical Scientist, Internal Medicine team supporting Ophthalmology. In this role, you will contribute to the development, evaluation, planning and execution of internal medicine clinical studies and ensure scientific integrity and interpretation of study data of a clinical development program.

Work in a matrix environment as part of a cross‑functional team (with internal and external vendor representation) and may contribute to candidate development projects through early and/or late phase development. You will report to the Sr Dir/Director, Clinical Science, Internal Medicine and collaborate closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. This position offers the opportunity to contribute to a fast‑growing, science‑driven organization making a meaningful difference to patients worldwide.

Location

Location: Tarrytown, NY; Warren, NJ; Cambridge, MA

Hybrid: 4 days per week on site

Role Overview

• May function as Clinical Scientist for program, and/or as delegate of Therapeutic area Clinical Scientist
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
• Maintains proficient 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
• Utilizes proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late‑stage assets; able to conceive and communicate strategy proposals well‑grounded in supporting literature
• Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments. Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross‑functional comments with minimal support
• Contributes to planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators
• Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
• Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program

Qualifications

• A bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc)
• ≥10 years of pharmaceutical clinical drug development experience, including basic knowledge of Ophthalmology
• Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrates solid medical writing skills
• Experience in all aspects of conducting global clinical trials and execution of clinical programs
• Strong team‑player; exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; demonstrates ability to influence within team and may influence across functions
• Demonstrates initiative, creativity and innovation skills. Directly or indirectly contributes to the development of innovations; identifies opportunities for process improvements
• Strong cross‑functional management, interpersonal skills, and attention to detail

Salary

Salary Range (annually): $176,100.00 – $287,300.00

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.

EEO Statement

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.