Medical Director

Role Overview

• Provides medical oversight of assigned clinical studies
• Interacts with senior management, customers, and project teams to ensure subject safety and scientific integrity of clinical studies
• Provides therapeutic area medical input and consultation to internal colleagues and customers
• Participates in business development meetings
• May participate in scientific meetings, upon request
• Performs the duties of Medical Monitor
• 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 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 medical coverage for clinical studies
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines

Requirements

• Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area
• Clinical research experience required
• In depth knowledge of FDA and worldwide drug development regulations
• Strong understanding of the use of medical terminology and of drug names in multiple nations and environments is required
• Experience working in matrix teams is preferred
• 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
• Above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills
• Ability to handle multiple tasks 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.

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
• We are committed to building an inclusive culture – where you can authentically be yourself
• Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life