Pre-Clinical Research Study Director/Scientist

Tarrytown, NY, United States
Jun 04, 2021
Required Education
Position Type
Full time
The R&pD Study Director/Scientist applies advanced knowledge of animal models (small and large animals) and pharmaceutical drug development to help advance drugs in development. We are seeking knowledge and experience of pharmacokinetic/pharmacodynamic (PK/PD) studies in nonhuman primates through worldwide contract research organization (CRO's). We need someone to work individually, or in collaboration with one or more Therapeutic Focus Area (TFA) leads, this person should be able to solve complex scientific problems using state-of-the-art approaches in pharmacology and related disciplines with minimal supervision.

As a Pre-Clinical Research Study Director/Scientist, a typical day may include the following:
• Apply knowledge of pharmacology to aid in assessment of various therapeutic modalities (antibodies, alternative protein molecules, siRNA, adenoviral) in all preclinical animal species, but particularly nonhuman primates.
• Facilitate the effective design, development, and implementation of detailed research studies to support development of new products.
• Maintain a deep understanding of leading contract research organizations (CRO's), their expertise and specific services and their study approval requirements across all major geographic regions.
• Design, implement, monitor and manage preclinical pharmacology and safety studies in consultation with scientific area experts (TFA scientists and/or TFA Head).
• Oversee and provide direction for data and report review and protocol preparation.
• Communicate effectively with all stakeholders (external CRO's, TFA etc) in writing, by teleconference and during face-to-face meetings as necessary.
• Review and evaluate data and reports of external preclinical pharmacology and toxicology studies.
• Develop and implement scientific strategies to resolve specific, unusual pharmacology or CRO specific problems or issues (eg drug and/or sample shipment).
• Establish and maintain positive and cooperative relationships across the organization.
• Develop and maintain appropriate external contacts to further the advancement of development programs (e.g., contract research organizations, industry-wide scientific societies, regulatory agencies, academic -research organizations).
• Ensure effective communication with line-management of all on-going project activities status, issues relating to programs and personnel
• Contribute to scientific publications as appropriate
• Contribute to the drafting and finalization of SOPs and working practices as requested.
• May provide mentoring and/or supervision to direct reports as assigned.

This role may be for you if:
• You are able to provide consultative pharmacology support to scientists and colleagues in other functional areas.
• You enjoy training and mentoring of more junior scientists within the preclinical therapeutic group.
• You are able to communicate clearly and effectively at all levels of the organization and to positively impact program strategy across disciplines.

To be considered for this position, you must have a MD/PhD/Vet Degree in Biological Sciences or related discipline with at least 5 years of relevant industry experience. Proven knowledge of abilities and practices of NHP CRO's world-wide. Ability to understand and optimize NHP studies for scientific vigor and appropriateness is required. Significant experience or training in the development of biologic therapeutics, siRNA or other molecules in non-human primates is essential for this position.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.