Medical Director (HIV Research Scientific Lead - Clinical/Observational Research)

Job Responsibilities

• Provides medical oversight of assigned clinical studies in the capacity as a medical monitor.
• Serves as the 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.
• Reviews Informed Consent Templates and Subject-Facing Materials, and inputs into site feasibility evaluations.
• Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
• Oversees 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.
• May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
• May provide input to clinical development or regulatory teams within the Company, upon request.
• May represent the Company at scientific meetings, upon request.

Qualifications

• 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.
• A 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.
• Up to 25% travel may be required.