Clinical Trial Lead

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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. 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 a deep understanding of fibrotic diseases and immunology.

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.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1521381_EN

Updated: 2020-02-18 00:00:00.000 UTC

Location: Jersey City,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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