Associate Director, Clinical Scientist, Ophthalmology

Regeneron Pharmaceuticals; Tarrytown (GA); In loco; USD 176.000 - 287.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Equity awards

Pension plan

401(k) match

Health insurance

Wellness programs

Paid time off

Family support benefits

Descrizione del lavoro

Regeneron Pharmaceuticals in the U.S. is seeking an Associate Director to join the Clinical Scientist team for Internal Medicine with a focus on Ophthalmology.

You will contribute to the development, evaluation, planning and execution of internal medicine clinical studies and ensure data integrity across a development program. In a matrix environment, you will lead cross-functional collaboration, author key trial documents, and support regulatory submissions while mentoring teams.

Competenze

• Bachelor’s degree required; advanced degree preferred.
• ≥ 10 years of pharmaceutical clinical drug development experience, including ophthalmology knowledge.
• Strong knowledge of GCP, study design, and clinical research methodology.
• Experience leading global clinical trials and programs.
• Excellent cross-functional communication and professional diplomacy.

Mansioni

• Serve as Clinical Scientist for the program or as delegate in the therapeutic area.
• Contribute to team meetings, advisory boards, and DSMBs; collaborate with other departments.
• Develop study documentation, medical monitoring plans, SAPs, and trial components with minimal guidance.
• Present data to external investigators and internal collaborators.
• Identify risks and design mitigation strategies.

Conoscenze

Clinical development

Ophthalmology knowledge

Medical writing

Cross-functional collaboration

Regulatory knowledge

Formazione

Bachelor's degree in life sciences or healthcare

Advanced degree (PhD/PharmD/MSc)

Descrizione del lavoro

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 ensures 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 collaborates 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.

When & where:

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

Discover your role:

• 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

This role requires:

• 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

• We need an individual who is a strong team-player; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to Influence within team and may influence across functionally

• Demonstrates initiative, creativity and innovation skills. Directly or indirectly contributes to the development of innovations; Identifies opportunities for process improvements

• You possess strong cross-functional management, interpersonal skills, and strong attention to detail

Does this sound like you? 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 other locations, additional information will be provided during the recruitment process.

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)

$176,100.00 - $287,300.00