Clinical Trial Lead, Fibrosis, Innovative Medicines Development
- Works with matrix team members and partners to translate development team strategy into protocols and action plans.
- Works with the relevant team members and partners to develop clinical protocols and related documents, including clinical study reports, clinical regulatory documents including integrated summaries and clinical overviews.
- In collaboration with pharmacovigilance, designs and implements safety monitoring plans.
- Provides key contributions to clinical documents and deliverables in support of regulatory submissions.
- Monitors one or more clinical trials for safety and experimental rigor.
- Reviews and cleans data from clinical trials.
- Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions.
- Cultivates relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs.
- Provides clinical support to medical affairs and commercial colleagues.
- MD, PhD, or MD/PhD required, preferably with a deep understanding of fibrotic diseases and immunology. Expertise in hepatology, gastroenterology and/or endocrinology preferred.
- At least 10 years of experience in clinical or translational research or in clinical practice in a relevant field.
- Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results.
- Understanding of the fundamentals of protocol development and execution, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock.
- Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements.
- Ability to work consistently in a matrixed environment with relevant teams such as operations, statistics, regulatory, pharmacovigilance and biomarkers.
- Ablility to lead multiple complex projects in parallel.
- The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects.