Associate Director, Clinical Research Physician, Neuroscience

Job description

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: 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 7 or more years of industry experience and/or registrational clinical trials experience (medical monitor) are required in neurology area Clinical practice experience as a neurologist 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