Sr. Regulatory Scientific Advisor

Evolution Research Group• US,

3d•Remote

About The Position

The Sr. Regulatory Advisor & Scientific Advisor provides senior-level regulatory and scientific guidance on FDA guidance and regulatory requirements, clinical reviews, and clinical trial design, conduct, and analysis. The Advisor also participates in Scientific Leadership Team meetings to help evaluate new opportunities. This is a remote, PRN position with a baseline commitment of approximately 5 hours per week. The Advisor is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. Evolution Research Group (ERG) delivers Phase I–IV clinical trial execution to help sponsors bring therapies to market safely and quickly. Founded in 2014, ERG is a neuroscience clinical development company with affiliate sites across the U.S. and expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Requirements

Medical degree (MD) or equivalent advanced scientific degree.
Extensive senior-level experience in clinical research and regulatory affairs.
Demonstrated experience with FDA guidance and clinical reviews.
Strong background in clinical trial design, conduct, and data analysis.
Ability to complete required training, including GCP, HIPAA, and company SOP training.
Ability to work independently and remotely, with availability for Monday and Wednesday afternoon meetings when possible.
Sound judgment and discretion in handling confidential and proprietary information.
Successful completion of a background check and drug screening, and signed non-disclosure and at-will employment agreements.

Nice To Haves

Experience evaluating new development opportunities and communicating clear, practical opinions to executive and scientific leadership.

Responsibilities

Provide guidance on FDA guidance and regulatory requirements as they apply to clinical research.
Perform clinical reviews and advise on findings.
Advise on clinical trial design, including protocol development and review, and on clinical trial conduct and analysis of trial data.
Offer scientific opinions on development programs and how regulatory expectations affect them.
Participate, as often as possible, in Scientific Leadership Team meetings held Mondays and Wednesdays from 4:00–5:00 p.m. Eastern Time.
Review emailed meeting agendas, topics, protocols, and related materials in advance of Scientific Leadership Team meetings.
Learn about new opportunities under consideration by the organization, offer opinions, and request involvement in projects where the company is open to it.
Agree in advance with company leadership on anticipated hours for specified advisory work.
Take on special projects only when discussed and approved in advance.
Maintain the confidentiality of company materials, information, and business plans, and use them only for the benefit of the company.
Maintain compliance with company policies, HIPAA requirements, and applicable regulatory standards.
Perform other duties as assigned to support clinical research and development activities.