The Associate Medical Director 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; provide input on potential disease areas/indications; and craft clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs. Evolving Genetic Medicines modalities include RNA Interference (RNAi), CRISPR gene editing, AAV gene delivery, and others.
As a Medical Director, a typical day might include the following:
- 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.
- Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives.
This role may be for you if:
- 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.
- You have the ability to work productively in a fast-paced collaborative working environment.
To be considered for this role, you must have:
- An M.D. Degree (M.D./Ph.D. Degree preferred) Board Certification/Eligibility in a relevant therapeutic area preferred, along with relevant industry experience.
- A minimum of 2-3 years (Associate Director), 4-8 years (Director) 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.
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
Salary Range (annually): $235,300.00 - $318,300.00
