BeOne Medicines

Executive Medical Director

BeOne Medicines

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $316,200 - $396,200 per year

Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Support BeOne Clinical and Medical assets within the Hematology franchise by developing early and late phase clinical development strategies
  • Work in partnership across the organization, with external vendors, academicians and collaboration partners
  • Report to the Vice President of Clinical Development Hematology
  • Participate in clinical program strategy and ensure activities executed within scope, budget, and timelines
  • Establish and grow Clinical Research functions to ensure global capabilities and execution
  • Collaborate with clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research
  • Author, update, and review key documents including protocols, informed consent, investigator brochures, clinical study reports, manuscripts, INDs, NDAs, and health authority documents
  • Partner with clinical operations for successful implementation and execution of clinical studies
  • Provide scientific expertise for investigator and vendor selection
  • Provide scientific and medical support during clinical trials and respond to queries from sites, IRBs, Health Authorities, and CROs
  • Review, query, and analyze clinical trial data; interpret and present data internally and externally
  • Represent clinical study or development program on teams or subteams; create study-related slide decks
  • Build and maintain opinion leader/investigator networks; organize advisory boards and investigator meetings
  • Conduct therapeutic area research and competitor analysis; identify process improvement and resource needs
  • Develop, track, execute and report on goals and objectives; support budget planning and management
  • Ensure compliant business practices and foster global competencies

Requirements

  • Advanced degree (MD or MD equivalent) with subspecialty training in hematology/oncology (preferred)
  • 8 plus years of experience within other biotech/pharmaceutical or relevant academic credentials
  • Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials
  • Clinical oncology experience; exceptional experience in other therapeutic areas considered
  • Expert understanding of global clinical study design and drug development process
  • High level of communication, interpersonal, organizational, and cross functional collaboration skills
  • Knowledge of GCP and ICH Guidelines
  • Flexibility to work with colleagues in a global setting
  • Able to engage in work-related travel approximately 25%
  • Strategic leader with demonstrated success building, managing and developing individuals and teams preferred
  • Experience with SOPs and policies development and support
  • Knowledge of industry standard Clinical Development IT solutions
  • Executive presence; values-based collaborator
  • Impactful written and verbal scientific communication
  • Successful influencing skills across all levels
  • Problem solving and risk-mitigation skills
  • Strong time management and organizational skills
  • Skilled in multiple computer-based tools, including MS Office