Senior Medical Director - Psychiatrist - Remote Based

Syneos Health/ inVentiv Health Commercial LLC; Rhode Island; Remote; USD 180,000 - 220,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Medical Director - Psychiatrist. The role involves providing medical oversight for clinical studies, contributing to drug safety, and leading training efforts. Candidates must have a medical degree, board certification in psychiatry, and significant experience in clinical development and regulatory submissions. This is a remote-based position with responsibilities including mentoring staff and handling after-hours coverage, offering a competitive benefits package.

Benefits

Health coverage

Retirement benefits

Paid time off

Qualifications

• Medical degree with board certification in psychiatry and active medical licensure.
• Extensive experience in clinical development, medical oversight, pharmacovigilance, and regulatory submissions.
• Strong knowledge of FDA and worldwide drug development regulations and ICH GCP guidelines.
• Experience in leading cross-functional teams, mentoring staff, and client-facing medical communications.
• Ability to work remotely, handle after-hours coverage, and manage multiple projects simultaneously.

Responsibilities

• Provides medical oversight of assigned clinical studies as the medical monitor.
• Provides medical input and oversight in support of Drug Safety and Pharmacovigilance.
• Responsible for protocol design and development.
• Develops and delivers project-specific training to project team members.
• Provides medical input to Study Start Up and Feasibility activities.
• Oversees assigned Medical Scientist staff to review clinical data.
• Provides after-hours coverage for clinical studies.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations.
• Leads medical responses to RFPs and BD meetings.
• Mentors staff to ensure understanding of sound treatment principles.
• Assumes line management duties as needed.

Job description

Overview

Senior Medical Director - Psychiatrist - Remote Based. Syneos Health is a leading fully integrated biopharmaceutical solutions organization. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient, aiming to simplify and streamline work. This posting is for a potential upcoming opportunity; you will be considered should the role become available.

Responsibilities

• Provides medical oversight of assigned clinical studies as the medical monitor and primary medical contact for customers.
• Provides medical input and oversight in support of Drug Safety and Pharmacovigilance.
• Responsible for protocol design and development, and input into protocol amendments upon request.
• Develops and delivers project-specific and therapeutic training to project team members, clinical site staff, and customer staff as needed.
• Provides medical input to Study Start Up, Feasibility, and Subject Identification activities, including review of Informed Consent Templates and Subject-Facing Materials, and site feasibility evaluations.
• Provides medical input into data collection tools, monitoring plans, and analysis plans.
• Oversees assigned Medical Scientist staff and Medical Director colleagues to review clinical data; presents trends and mitigation strategies to minimize risks to subject safety or data integrity.
• Provides after-hours coverage for clinical studies.
• Adheres to enterprise and customer policies, SOPs, and project plans.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and ICH GCP guidelines.
• Leads medical responses to RFPs and BD meetings; may support RFIs.
• Contributes to development of product/clinical development plans and collaborates on reports, applications, and regulatory submissions; engages external experts/consultants as needed.
• Represents the Company at scientific and industry meetings and may publish related articles.
• Mentors staff to ensure understanding of sound treatment and research principles within the therapeutic area and ensures compliance.
• Assumes line management duties as needed.

Qualifications

• Medical degree with board certification in psychiatry and active medical licensure as applicable.
• Extensive experience in clinical development, medical oversight, pharmacovigilance, and regulatory submissions.
• Strong knowledge of FDA and worldwide drug development regulations and ICH GCP guidelines.
• Experience in leading cross-functional teams, mentoring staff, and client-facing medical communications.
• Ability to work remotely, handle after-hours coverage, and manage multiple projects simultaneously.

Additional Information

Benefits may include health coverage, retirement benefits, and paid time off. The information provided reflects the role as described and may be subject to change.