Medical Director, Addiction Research & Pharmacotherapy

Job Type


Full-time

Description

The Medical Director, Addiction Research & Pharmacotherapy will senior clinical and scientific leadership in support of National Institutes of Health (NIH)-funded research focused on Alcohol Use Disorder (AUD) and related substance use disorders. Reporting to the Chief Science Officer, this position will serve as a subject matter expert in addiction medicine, pharmacotherapy, and clinical trial conduct, supporting protocol development, participant safety oversight, medical monitoring activities, data interpretation, and regulatory compliance.

The Medical Director will collaborate with investigators, sponsors, Data and Safety Monitoring Boards (DSMBs), regulatory stakeholders, and multidisciplinary research teams to ensure scientifically rigorous and clinically sound medication-development research.

Essential Duties and Responsibilities

• Provide clinical and scientific leadership for studies evaluating novel, repurposed, or approved pharmacologic treatments for Alcohol Use Disorder and related substance use disorders.
• Serve as a clinical subject matter expert supporting study design, protocol development, endpoint selection, eligibility criteria, and safety monitoring plans.
• Advise research teams on addiction medicine, behavioral health, and pharmacotherapy-related clinical considerations.
• Support medical monitoring activities, including review of adverse events, serious adverse events, protocol deviations, participant safety concerns, and medical-risk escalations.
• Participate in safety reviews, DSMB activities, and study oversight meetings.
• Contribute to the interpretation of study findings and clinical significance of safety and efficacy outcomes.
• Assist in the preparation and review of clinical study reports, regulatory documentation, DSMB materials, and sponsor communications.
• Support development of FDA-facing, NIH-facing, and other regulatory-facing scientific materials.
• Collaborate with investigators and research teams in the preparation of manuscripts, presentations, and scientific publications.
• Provide clinical consultation to multidisciplinary teams, including biostatistics, clinical operations, regulatory affairs, and data management personnel.
• Ensure compliance with Good Clinical Practice (GCP), applicable federal regulations, protocol requirements, and organizational quality standards.

Requirements

Required Qualifications

• M.D. or D.O. degree required.
• Current unrestricted medical license in at least one U.S. jurisdiction.
• Board certification in Addiction Medicine, Addiction Psychiatry, Psychiatry, Clinical Pharmacology, Internal Medicine, Family Medicine, or a related specialty.
• Minimum of 10 years of clinical, research, or pharmaceutical industry experience involving substance use disorders, behavioral health, central nervous system disorders, or pharmacotherapy development.
• Demonstrated expertise in Alcohol Use Disorder diagnosis, treatment, and pharmacologic management.
• Experience supporting GCP-regulated clinical trials.
• Ability to advise on protocol design, participant safety, endpoint interpretation, and clinical study conduct.
• Strong written and verbal communication skills.

Preferred Qualifications

• Prior experience serving as a Medical Monitor for clinical research studies.
• Experience supporting Alcohol Use Disorder pharmacotherapy trials.
• Experience with randomized, double-blind, placebo-controlled medication studies.
• Experience supporting research funded by the National Institutes of Health (NIH), including the National Institute on Alcohol Abuse and Alcoholism (NIAAA) or the National Institute on Drug Abuse (NIDA).
• Experience interacting with DSMBs, regulatory agencies, or federal research sponsors.
• Peer-reviewed publications related to addiction medicine, Alcohol Use Disorder, clinical pharmacology, behavioral health, or CNS therapeutics.
• Experience working within federal contracting environments and federally funded clinical research programs.

Knowledge, Skills, and Abilities

• Expert knowledge of Alcohol Use Disorder treatment and pharmacotherapy.
• Strong understanding of clinical trial methodology, participant safety monitoring, and medication-development research.
• Familiarity with FDA, ICH, and GCP requirements applicable to regulated clinical research.
• Ability to evaluate clinical risk, participant safety concerns, and adverse event trends.
• Excellent scientific, analytical, and clinical judgment.
• Strong collaboration and stakeholder engagement skills.
• Ability to communicate complex clinical and scientific concepts to diverse audiences.

Travel Requirements:

• Occasional travel to client sites, research facilities, or industry events may be required.

Work Environment:

• Remote-first, with flexibility to adapt to evolving program needs and organizational priorities.

Physical Demands:

• Ability to participate in virtual meetings, presentations, and program activities for extended periods.

Equal Employment Opportunity

Phronetik is an equal opportunity employer and is committed to creating a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to any protected status under applicable law.

Contingency Statement

This position is contingent upon contract award, funding availability, and satisfaction of all applicable employment requirements.

Salary Description


$250,000 - $315,000 annually