Associate Director, Senior Clinical Scientist

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. 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:

Position Summary

• Responsible for implementation, planning, and execution of assigned clinical trial activities in Early Clinical Development
• Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
• Serves as a primary source of medical accountability and oversight for multiple clinical trials.
• Provides clinical, medical and scientific expertise to cross-functional BMS colleagues

Duties/Responsibilities

• Participates in designing and developing 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 Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
• Provides oversight and medical accountability for multiple trials across early development clinical lifecycle Works on multiple trials across early development clinical lifecycle
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment
• Maintains a thorough understanding of assigned protocols and protocol requirements and educate team members Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required.
• Plans and leads the implementation of clinical study startup/conduct/close-out activities as applicable.
• 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
• Serve as primary contact for site-facing activities such as training and support for clinical questions. Manages site interactions for medical questions and education (including safety management guidelines). To support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
• Identify clinical data trends; provide trends and escalate questions to study physician.
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
• Develop clinical narrative plan and review clinical narratives.
• Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
• Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study
• Author/review abstracts, presentations, and manuscripts for external publications
• Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Qualifications

Specific Knowledge, Skills, Abilities:

• MD or DM in Clinical Pharmacology or Oncology
• 10+ years of experience in clinical science, clinical research, or equivalent
• Medical Monitoring experience in Early Clinical Development is desirable
• Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
• Experience in driving, managing and collaborating in a team/matrix work environment
• Recognized internally and externally as a Therapeutic Area and Functional expert
• Domestic and International travel may be required %).
   

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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