Skip to main content

This job has expired

You will need to login before you can apply for a job.

Clinical Trial Lead, Fibrosis, Innovative Medicines Development

Employer
Bristol Myers Squibb Company
Location
Princeton, NJ, United States
Start date
Apr 23, 2019

View more

Discipline
Clinical, Clinical Trials
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

Facebook Instagram Twitter YouTube Logo

Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert