Working with Us
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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.
Position Summary / Objective
The Associate Director, Clinical Research Physician drives clinical strategy, and the design, execution, and interpretation of studies to ensure scientific inputs and high quality of delivery for early and late development projects in China.
Serves as a primary source of medical accountability and oversight for multiple clinical trials
Manages Phase I/II/III 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
Serve as an independent Medical Monitor for clinical trials 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
Contributes to and is a key member of a high performing Study Team (ST) and a member of the China Development Team (DT)
Provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
Provides oversight and medical accountability for multiple trials across development clinical lifecycle
Leads medical data review of trial data, including eligibility review
Holds responsibility for site interactions in partnership with global clinical trial physician and/or 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
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Clinical Development Expertise & Strategy
Ensure clinical development activities are addressed with aligned strategies in close collaboration with cross function team
Provide inputs into clinical 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, in collaboration with China Development Team
Set up disease area strategy for clinical development activities in China, including but not limit to China-led study/indication (e.g. early signal detection) and major patient and investigator contribution in MRCT, to ensure development/study readiness in China from unmet needs, clinical capability, and competitor practice, and trial methodology perspective, with continuously update of knowledge and intelligence of designated disease area.
Maintain direct contact and develop strong peer-to-peer scientific partnerships with external clinical experts to gather insights and input on disease area information.
Explore collaborative connections with external China experts in academic/scientific database, patient cohorts, as well as real-world research to get insights on disease area information such as disease biology progress, treatment effect prediction, as well as innovative development methods.
Identify China clinical development opportunities on top of global development strategy/plan to enrich the LCM of neuroscience assets
Provide inputs and participate collaborative relationships with internal and external stakeholders (GPT/CDL, Opinion Leaders, Patient Advocacy Leaders, Health Authorities) and appropriately incorporate insights and advice to maximize program impact.
Ensure China inputs are timely integrated into global clinical documents (e.g., CDP/study protocol/study report) through the drug development process.
Manage all issues to ensure studies are designed and conducted in alignment with scientific quality, and in compliance with our SOPs and regulatory requirements
Provides oversight and medical accountability for a group of studies
Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment
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
Health Authority Interaction & Publications
Contributes to key Health Authority interactions and advisory board meetings as Therapeutic Area Lead; 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
Degree Requirements
MD required (or x-US equivalent)
Experience Requirements
K
ey Competency Requirements
Extensive experience in leading, designing and managing clinical development programs and/or clinical trials across different phases of development in neuroscience area with Alzheimer's disease as a plus
Building strong relationships with External Experts in Neurology, Alzheimer’s disease as a plus
Solid understanding of medical oversight of clinical studies and statistical methods in clinical trials
Strong understanding of relevant regulatory health authority expectations and regulations for drug development and impact on commercialization.
§ Demonstrated scientific acumen and mechanistic understanding of pharmacology and disease biology.
§ Ability to effectively and seamlessly multi-task, and prioritize across multiple development assets, with complex strategies and accelerated development timelines.
§ Demonstrated ability to successfully and effectively cooperate, collaborate and work across functions.
§ Demonstrated ability to advise and participate in business development due-diligence evaluations and transaction recommendations. Ability to communicate information clearly and lead presentations in scientific and clinical settings
§ Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
§ Expertise in drug development process
§ Expertise in the components needed to execute an effective clinical plan and protocols
§ Strong leadership skills with proven ability to lead and work effectively in a team environment
§ Intermediate-to-professional medical writing skills and medical terminology
§ Good interpersonal skills, can-do attitude. Intermediate critical thinking and problem-solving skills
§ Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
§ Good language skill in English and Mandarin (verbal and written), good computer skills (Microsoft Word/Excel/PowerPoint and data review tools)
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.
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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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/
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R1604253 : Associate Director, Clinical Research Physician, Neuroscience
