layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Director, Global Clinical Physician - Oncology at Bristol Myers Squibb | LAYIQ

Serves as a primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within [TA] Clinical Development group
Supervises the development, monitoring, analysis, and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings.
Will contribute to overall Therapeutic Area disease strategy while ensuring an overall portfolio view
Provides strategic insights into clinical development plans
Provides medical and scientific expertise to cross-functional BMS colleagues
Matrix management responsibilities across the internal and external network
Manages Phase 1 to Phase 3 clinical studies, with demonstrated decision-making capabilities
The role will be foundational in working with teams in Research, Early and Late Development teams to support gated investment decisions and transitions, providing insights into biology, translational elements as well as overall benefit risk assessments
Clinical Development Expertise & Strategy: A Senior Director, Global Clinical Physician is a tenured drug developer who can independently design and construct clinical development plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets.
Done in conjunction with Clinical Development Program Lead or as a delegate when CDPL is not assigned
Extensive experience in Research and Development (late and/or early development) and across various Phases of study design
Respected for Disease Expertise (internal to BMS and within the medical community)
Disease Lead- able to serve as internal consultant for respective disease(s) based on scientific knowledge and therapeutic expertise
Provides oversight and medical accountability for a group of high-priority studies
Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Global Clinical Scientists (CS)
Partners with CS to support executional delivery of studies
Existing strong relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
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
Senior CTP II should be able to anticipate impact of external data which may shift internal clinical strategy and proactively assess needs for internal program (ie amendments, need for ad hoc analyses & implications to execution of internal programs)
Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and internal stakeholders
Medical Monitoring: Leader of high performing Study Delivery Team (SDT) and key member of the Clinical Development Team (CDT)
Study-Leader with ability to own/drive study level strategic decisions
Leads medical data review of trial data, including eligibility review
Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
Leads collaboration with CS and inputs into protocols, providing 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
Onboarding Lead – provides guidance and training to new CTP (not limited to data management; systems training), therapeutic training, innovative study design and sets example of high proficiency for the organization
Health Authority Interactions & Publications: Serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
Authors clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs
Experience with regulatory submission & development of clinical sections in regulatory documents for submission across several markets
Ability to lead strategic framework for clinical sections of regulatory documents
Exceptional clinical response strategist for queries (written & oral) Stakeholder Engagement and Communication
Be recognized internally and externally as an expert in the field.
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof-of-concept trials and will assure a seamless transition into late-stage development (Phase II-III trials.)
Ability to influence leadership and upper management of key functions, applying foresight, scientific and development knowledge to ensure support of late clinical development needs and adequacy of clinical studies leading to registration

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1607070 : Senior Director, Global Clinical Physician - Oncology

Senior Director, Global Clinical Physician - Oncology

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