Senior Medical Director – Psychiatry

Role Overview

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies.
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department.
• Responsible for protocol design and development, upon request. Provides input into protocol amendments.
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed.
• Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations.
• Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data.
• Provides after-hours coverage for clinical studies.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
• Leads medical responses to Requests for Proposals (RFPs) and Bid Defense Meetings (BDMs). May support Requests for Information (RFIs).
• Contributes to the development of product/clinical development plans, and collaborates with customer and internal colleagues regarding other reports, applications, and regulatory submissions. Locates and engages external experts/consultants/advisors as necessary.
• Represents the Company at scientific and industry meetings. May publish scientific or industry-related articles in industry journals, as requested.
• Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area. Ensures project teams consistently operate in compliance with such principles.
• Assumes line management duties as needed.

Requirements

• Doctorate degree in medicine and significant clinical experience in the practice of medicine in specific therapeutic area. Psychiatrist is a requirement
• Significant clinical research and demonstrated leadership experience
• A strong understanding of the use of medical terminology and of drug-names in multiple nations and environments
• Experience working in matrix teams required
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail
• Effective organizational and interpersonal skills, communication and language skills, and group presentation skills
• Ability to handle multiple priorities to meet deadlines in a dynamic environment is essential
• Ability to be customer-focused and have a disciplined approach to work is critical
• Fluency in written and spoken English is essential
• Travel up to 25% may be required.

Tech Stack

• Google Cloud Platform

Benefits

• We are passionate about developing our people, through career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Committed to building an inclusive culture