Senior Director – Medical Monitor, Immunology/Rheumatology

Stellenbeschreibung:

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.