Director, Business Development
IQVIA
Associate Medical Director, Cardiology, Metabolic Diseases and Nephrology
IQVIA
full-time
Posted on:
Origin: • 🇩🇪 Germany
Visit company websiteJob Level
Lead
About the role
- Provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested
- Participate in all aspects of Medical Science involvement on assigned trials and serve as a medical expert during project delivery lifecycle
- Serve as Global Medical Advisor on assigned projects and as Scientific Advisor to Project Leaders on medical/scientific aspects
- Provide medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and patient safety/eligibility
- Perform medical review of the protocol, Investigative Drug Brochure (IDB), and Case Report Forms (CRFs)
- Provide therapeutic area/indication training for the project clinical team and attend/present at Investigator Meetings
- Review and clarify trial-related Adverse Events (AEs) and may perform medical case review of Serious Adverse Events (SAEs) in collaboration with Pharmacovigilance
- Provide medical support for Analysis of Similar Events (AOSE) and may perform medical review of adverse event coding
- Review the Clinical Study Report (CSR) and patient narratives; attend Kick-Off meetings, weekly team meetings, and client meetings as needed
- Available 24/7 to respond to urgent protocol-related questions in accordance with local labor laws
- Provide therapeutic and medical expertise to business development activities
- May require regular travel to US (15%-20%)
Requirements
- Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required
- Minimum of 5 years' experience in clinical medicine
- Minimum of 4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry
- A board-certification for the required therapeutic
- Knowledge of cardiology, metabolic diseases and nephrology
- Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research
- Experience or knowledge in Phase I studies or early clinical development
- Fluent English
- Extensive communication skills
- Business Acumen
- Available 24/7 to respond to urgent protocol-related questions; may require regular travel to US (15%-20%)
