Bristol-Myers Squibb Company

Study Scientist, Cardiovascular - Innovative Medicines

Location
Princeton, NJ, United States
Posted
Sep 18, 2019
Ref
R1517694
Required Education
Doctorate/PHD/MD
Position Type
Full time
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

In this position, you will work as part of a team comprised of clinician researchers and scientists to support the design, execution, and interpretation of global clinical programs and regulatory submissions for a portfolio of anti-thrombotic medicines in our cardiovascular therapeutic area. The individual will focus on helping to support the execution of ongoing and new studies (e.g., support of IRB or regulatory responses).

Responsibilities
Work with the Clinical Program Lead and Clinical Trial Leads to develop and execute the broad clinical strategy and vision for an asset or indication through a multi-disciplinary matrix team across BMS and strategic partners.
Translate the overarching development strategy into clinical strategies and study protocols
Provide therapeutic/scientific insight into clinical strategies, protocol development and interpretation of data
Support the partnership with clinical, scientific and operational input into study protocols (rationale, objectives, and design). Update study presentation and training materials based on protocol amendments.
Formulate and execute investigative queries designed to further our understanding of clinical trial results, and translate insights to other studies / programs in development. Support aggregate data review by generating J-Review reports, organizing data, obtaining data from vendors and/or GBS.
Conduct rigorous, systematic reviews (e.g., literature, labeling) to gain learnings and understand precedent for the development of assets within the Cardiovascular therapeutic area.
Generate, review and coordinate clinical documents and deliverables (e.g., DSURs, PSURs, and Investigator Brochures) in support of clinical programs and regulatory filings
Support responses to relevant clinical queries from study sites
Assist in preparation of presentation decks to proficiently convey results and messages
Support the oversight of ongoing studies and put forward mitigation strategies as issues arise. Clean and interpret data from studies
Support the response process for Health Authority and Ethics Committee queries relating to clinical issues/topics.
Perform Quality Reviews for CTA submissions.
Review and providing suggested edits as needed to site and patient recruitment materials for ongoing studies.
Communicate effectively across the R&D organization including clinical development, regulatory, biostatistics and medical
Create synergy with stakeholders to develop strong alliances with the full team and external partners
Engage opinion leaders and therapeutic experts to generate insights and test assumptions
The position is based in the Princeton, NJ area.

Qualifications

PhD, Pharm D, or advanced degree, preferably with an understanding of thrombotic diseases affecting adults and children.

Experienced researcher with 3+ years of drug development and/or clinical experience.

Ability to formulate and execute (in collaboration with biostatisticians, biomarker scientists and other researchers) queries of clinical and other datasets to further the understanding of our medicines and translate learnings across program(s).

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, and data cleaning.

Working knowledge of functional areas of drug development, including, biology, toxicology, translational medicine, pharmacology, and clinical development (Phase I-IV).

Ability to consistently work in or lead matrixed teams.

Ability to conduct multiple complex projects in parallel.

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.