Associate Medical Director, Early Clinical Development

Location
Tarrytown, NY, United States
Posted
Sep 01, 2020
Ref
20924BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Associate Medical Director works with supervisor and other members of the cross-functional study team to author early clinical development protocols and facilitate execution of study activities and data summarization.A typical day might include the following:
  • Leads the cross-functional study team
  • Crafts POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per strategy.
  • Responsible for the relevance and accuracy of medical science underpinning of clinical study based on detailed scientific review and consultation.
  • Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments.
  • Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
  • Accountable for timely clinical trial execution and quality of resultss
  • Analyzes the benefits and risk aspects of an assigned therapeutic candidate
  • Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.
  • Authors clinical sections of communications/documentation for regulatory agencies and may participate in meetings as needed.
  • Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives.
  • Working with the ECD&ES Disease Area Lead, takes lead on various collaborations with TFA Research and Regeneron Genetic Center (RGC) colleagues to understand current and emerging targets/molecule program, provide input on potential disease areas/indications, and craft clinical experiments that corroborate or inform the biology for decision-making purposes.
This role might be for you if:
  • You want to make a broader impact on developing medicines for patients with serious diseases
  • You have experience in analysis of clinical and basic research information from a wide range of topics
  • You demonstrate critical thinking skills and sound decision making
  • You have effective communication and presentations skills (verbal and written)
  • You have the ability to work productively in a fast-paced collaborative working environment
To be considered for this position, you must have an MD or MD/PhD with Board Certification or Eligibility in a relevant area preferred. Experience in clinical research and/or basic science research in an academic setting preferred.

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.