Bristol-Myers Squibb Company

Clinical Lead, Immunoscience, Innovative Medicines Development

Location
Princeton, NJ, United States
Posted
Aug 09, 2019
Ref
R1510396
Required Education
Doctorate/PHD/MD
Position Type
Full time
What is Innovative Medicines at Bristol-Myers Squibb?
Innovative Medicines at Bristol-Myers Squibb is a global development and commercial division focused on the Cardiovascular, Fibrosis and Immunoscience therapeutic areas.
We are committed to innovative approaches to help patients prevail against serious diseases.
From research to patient-centric activities, we foster a collaborative culture and invest in meaningful developmental opportunities for our people. We focus on the activities that increase the speed of the development and delivery of our innovative treatments to patients in need of novel therapies.
We are a unique organization where team members are encouraged to have broad roles and to contribute beyond their functional area, all in an effort to accelerate medicines to patients.
We are a fast, adaptable and agile enterprise. Through narrowed focus, nimble decision making, and cross-functional coordination, we are fueling the growth of our marketed medicines and accelerating the delivery of our most promising assets in the pipeline.
Learn more about who we are and what we do for patients

Learn about our unique understanding of the immune system and how it connects our therapeutic areas.

Explore additional areas of exciting science at Bristol-Myers Squibb, including fact sheets on specific assets in our pipeline.

See the people behind our discoveries.

Most importantly, hear from our patients, who are at the absolute center of everything we do!

The Clinical Trial Lead (with a focus on Psoriasis) 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, and clinical regulatory documents.
• In collaboration with pharmacovigilance, designs and implements safety monitoring plans
• Provides 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 understanding of immunology and immune-mediated diseases. Expertise in rheumatology, dermatology, gastroenterology or transplant preferred.
  • 2-5 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 work on multiple complex projects in parallel
  • The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects