Medical Director (Must Have - Medical Monitoring - Oncology/Protocol Exp)

Medical Director (Must Have - Medical Monitoring - Oncology/Protocol Exp) Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25108823-OTHLOC-1500-2DPR-2DR Job Summary Medical Director responsible for medical oversight of assigned clinical studies, serving as primary medical contact for customers, and providing therapeutic input and medical monitoring across oncology protocols. Job Responsibilities Provides medical oversight of assigned clinical studies 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, and 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, including review of informed consent templates and subject‑facing materials. Provides medical input into data collection tools, monitoring plans, and review and analysis plans. Oversight of assigned Medical Scientist staff and Medical Director colleagues to review clinical data, presenting 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 enterprise policies, work instructions, SOPs, and project plans, including customer policies and SOPs. Maintains in‑depth knowledge of FDA, global drug development regulations, and ICH Good Clinical Practice (GCP) guidelines. May support responses to RFPs or BD meetings 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. Qualification Requirements Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area. Clinical research experience is required. Candidate must have in‑depth knowledge of FDA and worldwide drug development regulations. Strong understanding of medical terminology and drug names in multiple nations and environments is required. Experience working in matrix teams is preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required. Effective organizational, interpersonal, communication, language, and group presentation skills are essential. Attention to detail, accuracy, organizational and team‑oriented skills are required. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Ability to be customer‑focused and disciplined is critical. Fluency in written and spoken English is essential. Up to 25% travel may be required. Benefits Company car or car allowance, health benefits (medical, dental, vision), company match 401(k), eligibility to participate in Employee Stock Purchase Plan, earnings incentives, flexible paid time off and sick time. Eligibility for paid sick time may vary by location. Compliant with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the company range for this position. Actual salary will vary based on qualifications, skills, and proficiency for the role. Additional Information Tasks, duties, and responsibilities listed in this job description are not exhaustive. The company, at its sole discretion, may assign other tasks. Equivalent experience, skills, and/or education will also be considered, and qualifications of incumbents may differ from those listed. Nothing contained herein shall be construed to create an employment contract. The company complies with EU Equality Directive and Americans with Disabilities Act, providing reasonable accommodations as appropriate. #J-18808-Ljbffr