Clinical Trial Physician Oncology Development

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Job Information

Bristol Myers Squibb

Clinical Trial Physician, Oncology Development

in

Princeton

New Jersey

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.

Experience

Required

MD required (or x-US equivalent) functional assignment as Clinical Trial Physician

3 or more years Industry experience and/or clinical trials experience required

Qualifications Desired

Subspecialty training in applicable therapeutic area

Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation

Knowledge of the drug development process

Knowledge of the components needed for an effective clinical plan and protocols

Strong leadership skills with proven ability to lead and work effectively in a team environment

Expected Areas of Competence

Matrix management responsibilities across the internal and external network

Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities

Provides medical and scientific expertise to cross-functional BMS colleagues

Ability to present clearly in scientific and clinical settings

Medical Monitoring

Contributes to and is key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)

Conducts medical data review of trial data, including eligibility review.

Responsible for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines

Responsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives.

Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations).

Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same

The Principles of ICH GCP

The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)

Medical Expertise

The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose

Trial Design

The sponsor should utilize qualified individuals (e.g., biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports

Clinical D evelopment E xpertise & Strategy

In collaboration with the CDL, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of the asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets. Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working in partnership with Clinical Scientists (CS)

Provides medical accountability and oversight of a group of studies

Partners with CS to support executional delivery of studies (eg, site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc)

Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders (TLs) in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge and design of clinical development studies and programs

Maintains a strong medical/scientific reputation within the disease area. Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area via attendance at scientific conferences and ongoing review of the literature

Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape

Provides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others

Health Authority I nteractions & Publications

Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician

Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filing of the study in partnership with CSs

Reporting and Developmental Value

Reports to Clinical Development Lead (CDL) who partners with GPV&E physicians in the ongoing review of safety data and potential safety signals, particularly clinical safety data arising from active and completed clinical trials

Broad experience in management of and participation in functional and cross functional based matrix teams

Gain a broad perspective of the pharmaceutical development process and the company's development strategy

Hands-on exposure in the development and execution of clinical development plans

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:

R1522853_EN

Updated:

2020-03-04 00:00:00.000 UTC

Location:

Princeton,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

Bristol-Myers Squibb Company
Website : http://www.bms.com