Sr. Regulatory Scientific Advisor

Title: Sr. Regulatory Advisor & Scientific Advisor (PRN) Location: Remote Reports to: Lori Wright, Chief Executive Officer Status: PRN (Pro Re Nata), non-exempt

About us:

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep 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.

Job Description:

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 the 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. In executing these position responsibilities, the Advisor is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities:

• Provide guidance on U.S. Food and Drug Administration (FDA) guidance and regulatory requirements as they apply to clinical research.
• Perform clinical reviews and advise on their findings.
• Advise on clinical trial design, including protocol development and review, and on clinical trial conduct and the analysis of trial data.
• Offer scientific opinion on development programs and on how regulatory expectations affect them.
• Participate, as often as possible, in the Scientific Leadership Team meetings held Mondays and Wednesdays, 4:00–5:00 pm 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 the anticipated hours required for specified advisory work.
• Take on special projects only when discussed and approved in advance.
• Maintain 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.

Skills and Qualifications:

Education and experience

• Medical degree (MD) or equivalent advanced scientific degree required.
• Extensive senior-level experience in clinical research and regulatory affairs required.
• Demonstrated experience with FDA guidance and clinical reviews required.
• Strong background in clinical trial design, conduct, and data analysis required.
• Experience evaluating new development opportunities and communicating clear, practical opinions to executive and scientific leadership preferred.

Requirements

• 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.

Working Conditions and Other Information Equipment and Material Used

• Standard office equipment including computer, telephone, video conferencing, and internet access.

Physical Tasks

• Sitting and viewing computer screens for long periods of time
• Extensive repetitive hand/wrist movements (telephone and computer keyboard)

Environmental Demands and Potential Hazards

• Remote home-office setting. No exposure to clinical areas, biological samples, or hazardous compounds is expected in this position.
• Exposure to hazards from video screens and computers.

Important Note This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to the job.