Senior Clinical Scientist

As a Senior Clinical Scientist you will be accountable for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. Experience with Cardiometabolic diseases and Cardio outcome trials is needed to thrive in this position.

Main Responsibilities:

• Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (eg, CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP);
• Provides clinical and scientific input and contributes to clinical sections of trial and program level regulatory documents (eg, Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities);
• Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead;
• Manages patient safety reports on trial data to safety and clinical boards (eg, Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead;
• Supports Clinical Development Head (CDH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
• Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule;
• May serve as speaker for franchise medical/scientific training.

Requirements:

• 3+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases (I to IV) and conducting clinical trials;
• 2+ years Conducting clinical trials in a global/Matrix environment in pharmaceutical industry;
• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred;
• Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level;
• Demonstrated ability to establish effective working relationship with key investigators;
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes