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 CV RM (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, I nvestigators /S ites 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 (GC H ) 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 C onsent Form , Case R eport F orms, and S afety and R isk -B ased M onitoring P lans) Is accountable for ensuring that safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting , the quer ying of missing/unclear data, the review of blinded safety data , and the escalat ion to the GC H /Global Safety Physician when needed. Is medically accountable for international investigator meetings, and support s Marketing Companies (MC) in national activities Approves (with the GC H ) 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 l eadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or L ife C ycle M anagement studies 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 Maintains a high degree of understanding and awareness on new and emerging medical development, globally. Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues <