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Job description
The Executive Companion Diagnostic (CDx) Lead, GMA, will support BeOne Clinical and Medical assets by successful execution of Global Medical Affairs Companion Diagnostic program, working closely with commercial CDx program as well as inform Clinical Development in informing their CDx strategy. The candidate will report to the Vice President, Global Medical Affairs, Solid Tumors. As a leader in the organization, the incumbent will be involved in developing and executing a CDx Global Medical Strategy as well as working closely with the commercial CDx lead and Clinical Development CDx lead to inform future CDx strategy. The CDx program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will work closely with colleagues in global medical affairs, clinical development, program leadership, biometrics, clinical operations, and translational research.
Essential Functions of the Job
Develop a Global CDx medical Affairs Strategy
Support and implement cross-functional plan for successful CDx launch programs
Generate clinical and real-world evidence (eg 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 any data generation efforts utilizing LDTs of follow-on CDx testing, aligning with overall global CDx strategy.
Provide global (inclusive of regional) insights into pipeline programs requiring CDx
Engage key opinion leaders (KOLs) in pathology and oncology to ensure successful launch of CDx
Cross-functional support of market launch readiness, aligning with commercial CDx activities.
Engage in feedback and advice from KOLs (oncologists and pathologists) on minimizing barriers and optimizing utilization of CDx, as well as validate future data generation needs.
Internal training of medical teams and field teams, with right-size training on CDx.
Support scientific publications
Provide medical review of diagnostic materials (PRC, MRC etc)
When appropriate be the GMA representative at Alliance partnerships
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 is required.
8 plus years of experience within other biotech/pharmaceutical company.
Clinical solid tumor oncology experience and former CDx medical experience is mandatory for this role.
Previous experience in Medical Affairs in a CDx role is strongly preferred.
Expert understanding of incorporation of biomarker and development of CDx in a global clinical study.
Deep understanding of LDTs and extent of data generation to support launch of CDx and utilization of companion-drug.
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 is preferred.
Experience with the development and support of related SOPs and policies is expected.
Knowledge of industry standard Clinical Development IT solutions expected.
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.
Travel
25%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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Worksite address
san mateo, CA, 94409, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.