Senior Director, Global Clinical Program Lead

As a Senior Director, Global Clinical Program Lead, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The successful Study and Program Clinical Lead in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases) will be responsible for the design, conduct, monitoring, data interpretation and reporting of clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as will allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements. 

Responsibilities

• Provides strategic medical and scientific knowledge (Cardiovascular, Renal, Metabolic, and/or Liver Disease) 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 

• Often works as a Global Clinical Head (GCH) delegate across several studies (e.g. a paediatric programme, or a set of mechanistic / differentiating studies) 

• Can be the clinical representative on indication Global Product Teams and/or other sub-teams 

• Has the knowledge to work across projects, with a fast learning curve when moving into new disease area 

• 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