Global Development Medical Director

About the Company

Responsibilities

• ● Provides strategic medical and scientific knowledge (Cardiovascular, Renal, Metabolic, and/or Hepatic Diseases) and supports the design, initiation, execution, completion, and interpretation of a clinical study
• ● Is accountable for study designs
• ● Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites
• ● Trial conduct and hands-on delivery accountabilities
• ● Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies
• ● Is responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the study team
• ● Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP
• ● Is accountable for delivery of the clinical components of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
• ● Is accountable for ensuring that safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and the escalation to the GCH/Global Safety Physician when needed.
• ● Is medically accountable for international investigator meetings, and supports Marketing Companies (MC) in national activities
• ● Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).
• ● Is accountable for ST induction and education of new members in the study team, as well as others involved in the study
• ● Collaborates seamlessly and efficiently with global colleagues at other R&D sites
• ● May be accountable to GCH (or delegate) and leadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or Life Cycle Management studies
• ● Scientific medical analytical accountabilities
• ● Stays updated on relevant scientific literature
• ● Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
• ● Serves as a source of medical expertise for the Product Team, in analyses and interpretation of medical data
• ● Messaging and external impact accountabilities
• ● Maintains a high degree of understanding and awareness on new and emerging medical development, globally.