Clinical Trial Lead, IBD, Immunoscience, Innovative Medicines Development

JOB DESCRIPTION
The Clinical Trial Lead working specifically with Inflammatory Bowel Disease (IBD) works with stakeholders across the organization to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, clinical, regulatory, and commercial objectives. The Clinical Trial Lead reviews and interprets clinical data, and guides appropriate recommendations and decisions, and contributes substantially to regulatory submissions. He/she will work on assets within our immunoscience therapeutic area, in support of a rapidly growing portfolio of assets, in both early and late phase development.
This position is based in the Princeton, NJ area.

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, investigator brochures, 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 summarizes data from clinical trials
• Makes effective presentations to clinical teams and stakeholders
• 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, MD/PhD required, preferably with a deep understanding of immunology and immune-mediated diseases. Expertise in rheumatology, dermatology, gastroenterology or transplant 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.
• Able to work consistently in a matrixed environment with relevant teams such as operations, statistics, clinical pharmacology, regulatory, pharmacovigilance and biomarkers.
• Able 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