Senior Clinical Trial Physician, Hematology

Bristol Myers Squibb•Princeton, NJ

12d

About The Position

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Trial Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. Scope of Responsibility: Clinical development studies and/or programs: Contributes to and is key member of a high performing Study Delivery Team (SDT) and is a key member of the Clinical Development Team (CDT) 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). Conducts medical data review of trial data, including eligibility review. Responsible for site interactions 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 . Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same Clinical development expertise & strategy: Collaborates with CS on protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations); signs off on protocol. 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 interactions & 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) 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

Requirements

MD required (or x-US equivalent) functional assignment as Clinical Trial Physician
3 or more years Industry experience with clinical trials required

Nice To Haves

Subspecialty training in oncology and/or hematology or 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
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 BMS colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments
Ability to present clearly in scientific and clinical settings

Responsibilities

Contributes to and is key member of a high performing Study Delivery Team (SDT) and is a key member of the Clinical Development Team (CDT)
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).
Conducts medical data review of trial data, including eligibility review.
Responsible for site interactions 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
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same
Collaborates with CS on protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations); signs off on protocol.
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.
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.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

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