Medical Director, Clinical Sciences Lead

3 weeks ago

Tarrytown, New York, United States BioSpace, Inc. Full time

The Medical Director, Clinical Sciences Lead works with their supervisor and other members of the cross-functional study team to author protocols and facilitate execution of study activities and data summarization.

Takes lead on collaborations with discovery scientists and translational colleagues to understand current and emerging genetic targets across a variety of therapeutic areas and disease states including but not limited to cardiovascular and metabolism, rare diseases, and others; and craft clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs.

Key Responsibilities:

  • Leads the cross-functional study team to craft novel clinical development strategy for genetic medicines, including First in Human (FIH), Phase 2, and Phase 3 clinical trials
  • Responsible for the relevance and accuracy of medical science underpinning of clinical study based on detailed scientific review and consultation
  • Authors, reviews, and finalizes the medical and scientific portions of study strategies and clinical study protocols (CSPs) and amendments
  • Authors, 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, reviewing adverse events, monitoring patient health, and quality of results
  • 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

Requirements:

  • You want to make an impact delivering genetic medicines for patients with serious diseases
  • You have specialist postgraduate clinical training and practice, and/or scientific research training and with a track record of success
  • You demonstrate critical, science-to-medicine translational thinking skills and sound decision making
  • A minimum of 2-3yrs of prior industry experience or practice experience, preferably in a research/academic setting. Experience in analysis of clinical and basic research information from a wide range of topics.

About Regeneron:

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.

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