Executive Director, Global Medical Affairs – Companion Diagnostic Lead

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BeOne Medicines

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10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness