Senior Director – Medical Monitor, Immunology/Rheumatology

Darum lohnt es sich

• 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 oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Represents the Company at scientific and industry meetings • Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area Requirements • 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 • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines • Represents the Company at scientific and industry meetings Core Competencies Demonstrates expertise in medical oversight of clinical studies, including protocol design and development, while ensuring compliance with FDA regulations and ICH Good Clinical Practice guidelines.

Capable of providing training and mentorship to project teams and clinical site staff, with a focus on drug safety and pharmacovigilance.

Highest-signal resume keywords • Medical Oversight • Protocol Design • Drug Safety • Pharmacovigilance • Good Clinical Practice (GCP) Hard Skills • Clinical Study Oversight • Protocol Development Soft Skills • Mentoring • Training Delivery • Communication Industry Keywords • FDA Regulations • ICH Guidelines • Therapeutic Area Expertise • Clinical Data Integrity • Scientific Meetings