Medical Monitoring
• Serve as an independent Medical Monitfclinical trials by
• Articulating clinical development strategy
• Analyzing, interpreting, acting on clinical trial data to support development
• Serving as principal functional authfRegulatory submission, study reports, publications
• Contributes to is a key member of a high performing Study Team (ST) a member of the China Development Team (DT)
• Provides input protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion other safety-related clinical considerations)
• Provides oversight medical accountability fmultiple trials across development clinical lifecycle
• Leads medical data review of trial data, including eligibility review
• Holds responsibility fsite interactions in partnership with global clinical trial physician and/clinical scientist fmedical questions education (including safety management guidelines)
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety oversees contributions to safety narratives
• Fulfills GCP compliance obligations fclinical conduct 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 clinical plans protocols with a strong strategic focus based on knowledge of asset/drug, disease area relevant science inder to meet regulatory disease strategy targets, in collaboration with China Development Team
• Set up disease area strategy fclinical development activities in China, including but not limit to China-led study/indication (e.g. early signal detection) majpatient investigatcontribution in MRCT, to ensure development/study readiness in China from unmet needs, clinical capability, competitpractice, trial methodology perspective, with continuously of knowledge intelligence of designated disease area.
• Maintain direct contact develop strong peer-to-peer scientific partnerships with external clinical experts to gather insights 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 participate collaborative relationships with internal external stakeholders (GPT/CDL, Opinion Leaders, Patient Advocacy Leaders, Health Authorities) appropriately incorporate insights advice to maximize program impact.
• Ensure China inputs are timely integrated global clinical documents (e.g., CDP/study protocol/study report) through the drug development process.
• Manage all issues to ensure studies are designed conducted in alignment with scientific quality, in compliance with our SOPs regulatory requirements
• Provides oversight medical accountability fa group of studies
• Leads the analysis of benefit/risk fclinical development protocols in a matrix team environment
• Keeps abreast of development regulatory issues related to other competitive relevant compounds in development how our portfolio fits the competitive landscape
Health Authority Interaction & Publications
• Contributes to key Health Authority interactions advisory board meetings as Therapeutic Area Lead; serves as Primary Clinical Representative in Regulatory interactions fearly development projects
• Authors/drafts clinical content fCSRs, regulatory reports, briefing books submission documents to support closure, clinical narratives, reporting filling of the study
7 more years of industry experience and/registrational clinical trials experience (medical monitor) are required in neurology
area
Clinical practice experience as a neurologist
Extensive experience in leading, designing managing clinical development programs and/clinical trials across different phases of development in neuroscience area with Alzheimers 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 statistical methods in clinical trials
Strong understanding of relevant regulatory health authority expectations regulations fdrug development impact on commercialization.
Demonstrated scientific acumen mechanistic understanding of pharmacology disease biology.
Ability to effectively seamlessly multi-task, prioritize across multiple development assets, with complex strategies accelerated development timelines.
Demonstrated ability to successfully effectively cooperate, collaborate work across functions.
Demonstrated ability to advise participate in business development due-diligence evaluations transaction recommendations. Ability to communicate information clearly lead presentations in scientific clinical settings
Expertise in the scientific method to test hypotheses, including statistical design, analysis, interpretation
Expertise in drug development process
Expertise in the components needed to execute an effective clinical plan protocols
Strong leadership skills with proven ability to lead work effectively in a team environment
Intermediate-to-professional medical writing skills medical terminology
Good interpersonal skills, can-do attitude. Intermediate critical thinking problem-solving skills
Adaptable / flexible (willing able to adjust to multiple demands shifting priorities; ability to meet day-to-day challenges with confidence professionalism)
Good language skill in English Mandarin (verbal written), good computer skills (Microsoft Word/Excel/PowerPoint data review tools)
More
