Executive Director, Global Medical Affairs Companion Diagnostic Lead

About the role

The Executive Companion Diagnostic (CDx) Lead, GMA, supports BeOne Clinical and Medical assets by successfully executing the Global Medical Affairs Companion Diagnostic program. This role works closely with the commercial CDx program and informs Clinical Development's CDx strategy. Reporting to the Vice President, Global Medical Affairs, the incumbent develops and executes a CDx Global Medical Strategy while collaborating with the commercial CDx lead and Clinical Development CDx lead.

Responsibilities

• Develop a Global CDx medical Affairs Strategy
• Support and implement cross-functional plan for successful CDx launch programs
• Generate clinical and real-world evidence (e.g., IITs, testing utilization studies, diagnostic accuracy studies, clinical utility studies)
• Work closely with GMA disease lead to integrate the CDx strategy with the overall Medical Strategy
• Lead and oversee data generation efforts using LDTs for follow-on CDx testing, aligning with the global CDx strategy
• Engage in pipeline programs requiring CDx, providing global insights and engaging key opinion leaders (KOLs) in pathology and oncology
• Cross-functional support of market launch readiness, aligning with commercial CDx activities
• Engage in feedback and advice from KOLs on minimizing barriers and optimizing utilization of CDx, validating future data generation needs
• Internal training of medical teams and field teams, providing right-size training on CDx
• Support scientific publications
• Medical review of diagnostic materials (PRC, MRC, etc.)
• Develop, track, execute, and report on goals and objectives
• Support budget planning and management
• Be accountable for compliant business practices

Qualifications and Experience

• Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology
• Extensive experience in pharma/biotech in solid tumors
• 8+ years of experience within other biotech/pharmaceutical companies
• Clinical solid tumor oncology experience and former CDx medical experience mandatory
• Previous experience in Medical Affairs in a CDx role strongly preferred
• Expert understanding of incorporating biomarkers and developing CDx in global clinical studies
• Deep understanding of LDTs and extent of data generation to support CDx launch and utilization
• High level of communication (written and verbal), 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
• Experience with the development and support of related SOPs and policies
• Knowledge of industry-standard Clinical Development IT solutions

Other Qualifications

• Executive presence and ability to influence and lead
• Exceptional cross-functional collaboration within GMA and with other departments
• Accountable and results-driven
• Impactful written and verbal scientific communication
• Problem-solving and risk-mitigation skills
• Confident, positive attitude
• Flexibility and embracing change

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Pay

$296,600.00 - $376,600.00 annually

Schedule

Full-time