Clinical Trial Lead, Fibrosis, Innovative Medicines Development

Bristol Myers Squibb Princeton , NJ 08544

Posted 2 months ago

Responsibilities:

  • 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.

Qualifications:

  • 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.

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