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Job Details


Bristol Myers Squibb

Senior Director Early Clinical Development, Neuroscience

Business Development

Director

No

Cambridge, Massachusetts, United States

Working with Us
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 rich in diversity. 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

Director, Early Clinical Development

Functional Area Description

The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.

Position Summary / Objective

  • Serves as a primary source of medical accountability and oversight for multiple clinical trials
  • Manages Phase I/II studies, with demonstrated decision making capabilities
  • Provides medical and scientific expertise to cross-functional BMS colleagues
  • Maintains matrix management responsibilities across internal and external networks

Position Responsibilities

Medical Monitoring

  • Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by
    • Articulating clinical development strategy
    • Analyzing, interpreting, and acting on clinical trial data to support development
    • Serving as principal functional author for Regulatory submission, study reports, and publications
  • Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
  • Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
  • Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
  • Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
  • Collaborates with Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
  • Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
  • Acts as a focal point for defining and establishing relationships with key global Phase I Centers
  • Works on multiple trials across early development clinical lifecycle

Clinical Development Expertise & Strategy

  • Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies
  • Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
  • Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.