Medical Director – Psychiatry

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee medical aspects of clinical trials to ensure compliance with company SOPs, client instructions, good clinical practice, and regulatory standards.

• Participate in and deliver presentations at investigator and sponsor meetings.

• Offer medical advice to clients, investigators, project team members, and associates.

• Assist in business development initiatives.

• Conduct medical reviews and analyses of serious adverse events in clinical trials.

• Ensure that tasks assigned to medical monitors are executed effectively.

• Comply with relevant regulations, ICH guidelines, client instructions, corporate policies, SOPs, and study-specific WPDs.

• Provide therapeutic and protocol training for assigned studies.

• Monitor safety metrics, including adverse events, laboratory abnormalities, changes in patient medical status, restrictions on concomitant medications, and requests for un-blinding.

• Address medical issues with principal investigators and clients while interpreting inclusion/exclusion criteria.

• Review adverse events of particular interest, serious adverse events, and clinical outcome events.

• Conduct data review and validation, including coding listings and/or comprehensive safety data, to identify potential safety issues.

• Mentor and train other team members.

⛳️ Requirements

• MD or an equivalent degree is required.

• Active medical licensure is preferred but not mandatory.

• Clinical experience in Psychiatry along with formal training in Psychiatry (residency and/or fellowship).

• Patient treatment experience equivalent to at least 2 years.

• For the Senior Medical Director role: relevant clinical trial experience in a contract research organization or pharmaceutical company equivalent to 1–2 years.

• Preference for experience in clinical development/medical monitoring.

• Consideration may be given to a combination of relevant education, training, and/or directly related experience.

• Therapeutic expertise in Psychiatry is essential.

• Familiarity with relevant safety databases, such as MedDRA.

• Willingness to travel domestically and internationally as needed.

• Proficient in basic computer applications.

• Fluent in both spoken and written English.

• Knowledge of FDA, ICH, EMA, and GCP guidelines.

• Understanding of biostatistics, data management, and clinical operations procedures.

• Ability to successfully pass a comprehensive background check, including drug screening where applicable.

• Must be legally authorized to work in the hiring country without sponsorship.

• Consistent and regular attendance is required.

🏝️ Benefits

• Competitive salary.

• Annual bonus through an incentive plan.

• Healthcare coverage.

• A variety of employee benefits.

• Opportunities for career advancement and professional development.

• Innovative and progressive organization.

• Company culture that prioritizes integrity, intensity, involvement, and innovation.