Associate Director, Clinical Sciences, Internal Medicine

The Associate Director, Clinical Sciences contributes 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. Works 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. Reports 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.

As an Associate Director, a typical day may include the following:

• 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 may be for you:

• 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

To be considered for this role, 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 Metabolic disease and/or inflammatory disease areas. We are seeking proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrates solid medical writing skills. We need an individual who is a strong team-player. Experience in all aspects of conducting global clinical trials and execution of clinical programs. Other levels considered depending on experience. Experience in managing trials in one or more of the following therapeutic areas - cardiovascular, renal, metabolic and/or inflammatory disease - required. #Obesity

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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)