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Clinical trial lead fibrosis innovative medicines development

Bristol-myers Squibb

This is a Full-time position in Princeton, NJ posted May 23, 2019.

Summary The Clinical Trial Lead works with stakeholders across the organization to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives in lung fibrosis.

Lung fibrosis, including idiopathic pulmonary disease and other interstitial liver disease, is a key strategic pillar within Innovative Medicines Development, a global development and commercial division focused on the Cardiovascular, Fibrosis and Immunoscience therapeutic areas.

The Clinical Trial Lead reviews and interprets clinical data, guides appropriate recommendations and decisions, and contributes substantially to regulatory submissions This position is based in Lawrence Twp., New Jersey (PPK) 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 expertise in pulmonology and/or critical care, particularly with clinical experience in the management of IPF and/or ILD patients.

A history of research in fibrosis and immunology preferred.

At least5 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.

Ability 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.