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.

What is Innovative Medicines at Bristol-Myers Squibb?

Innovative Medicines at Bristol-Myers Squibb is a global development and commercial organization focused on Cardiovascular, Fibrosis and Immunoscience therapeutic areas.

We are committed to unleashing innovative approaches to help patients prevail against serious diseases. From research to customer-facing roles, we foster a collaborative culture and invest in meaningful development opportunities for our people and focus on the activities that increase the speed of the development and delivery of our innovative treatments. We are a unique organization where team members are encouraged to have broad roles and to contribute beyond a single discipline, all in an effort to accelerate medicines to patients. We are fast, adaptable and agile. Through 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. Learn more about who we are and what we do for patients

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 rapidly growing portfolio of medicines that have the potential to halt or reverse progression of tissue scarring that impacts organ function. The individual will focus on helping to: 1. ensure that data generated from our clinical trials are comprehensively interrogated to enable learnings to be applied across the portfolio; and 2. support the execution of ongoing 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).

Formulate and execute investigative queries designed to further our understanding of clinical trial results, and translate insights to other studies / programs in development

Conduct rigorous, systematic reviews (e.g., literature, labeling) to gain learnings and understand precedent for the development of assets within the fibrosis 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

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

Qualifications

PhD, Pharm D, or advanced degree. An understanding of fibrotic diseases and/or fibrotic processes of the liver and/or lung is a plus.

Experienced researcher with 5-10 years of drug development experience and/or translational immunology research

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.


Associated topics: hematopathology, medical laboratory science, microbiology, mls, molecular, scientist, services, technician i, technician iv, technologist

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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