Senior Director, Clinical Development, Breast Cancer

Role Summary

Senior Director, Clinical Development, Breast Cancer. Lead clinical development programs and deliverables for BeOne, partnering across the organization and with external vendors and collaborators to ensure programs meet scope, budget, and timelines. Drive establishment and growth of Clinical Research functions to support global capabilities and execution. Collaborate with clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Responsibilities

• Facilitate generation of, author, update, and/or review key documents, including protocols, informed consent documents, Investigator Brochures, clinical study reports, abstracts, posters and manuscripts, and clinical sections of INDs/NDAs, annual reports, and Developmental Safety Update Reports
• Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports; conduct risk/benefit analyses for applicable documents
• Develop Clinical Development Plans
• Partner with clinical operations and other functions for successful implementation and execution of clinical studies
• Provide scientific expertise for selection of investigators and vendors
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
• Review, query, and analyze clinical trial data
• Interpret and present clinical trial data internally and externally
• Represent a clinical study or development program on one or more teams or sub teams
• Create clinical study or program-related slide decks for internal and external use
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Build strong relationships with internal experts
• Identify continuous process improvement opportunities
• Identify incremental organizational resource needs – staff, budget, and systems
• Develop, track, execute and report on goals and objectives
• Support budget planning and management
• Be accountable for compliant business practices

Qualifications

• 6+ years of experience in biotech/pharmaceutical or relevant academic organizations
• Advanced degree (MD or MD equivalent) with subspecialty training in oncology (preferred)
• Previous participation in a clinical development program, including involvement in all stages of clinical trials; ideally led at least one study from start to finish in a clinical scientist role
• Clinical oncology experience; exceptional experience in other therapeutic areas considered if transferable to oncology
• Expert understanding of global clinical study design and drug development from discovery to post-marketing
• Strong communication, interpersonal, organizational, and cross-functional collaboration skills
• Knowledge of GCP and ICH Guidelines
• Ability to work with a global team; travel approximately 25%
• Strategic leadership with experience building, managing, and developing teams is preferred
• Experience with development and support of SOPs and policies
• Knowledge of industry-standard Clinical Development IT solutions

Skills

• Clinical study design and execution
• Regulatory and safety reporting
• Data interpretation and scientific communication
• Stakeholder management and teamwork
• Budgeting and resource planning
• Process improvement and SOP development

Education

• Advanced degree (MD or MD equivalent); oncology subspecialty preferred

Additional Requirements

• Able to travel approximately 25% for site visits, meetings, and external collaborations