Executive Director, Global Medical Affairs, Companion Diagnostic Lead

đź•’ July 8

🇺🇸 United States – Remote

đź’µ $296.6k - $376.6k / year

⏰ Full Time

đźź  Senior

đź‘” Director

đź‘» Ghost score 28%

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

đź’Š Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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 the 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.

đź“‹ Description

• Develop a Global CDx Medical Affairs Strategy • Support and implement cross-functional plans for successful CDx launch programs • Generate clinical and real-world evidence, including IITs, testing utilization studies, diagnostic accuracy studies, and clinical utility studies • Integrate CDx strategy with the overall Medical Strategy alongside GMA disease leads • Lead and oversee data generation efforts utilizing LDTs for follow-on CDx testing • Provide global and regional insights into pipeline programs requiring CDx • Engage pathology and oncology KOLs to support successful CDx launches • Support market launch readiness and align with commercial CDx activities • Gather KOL feedback on minimizing barriers, optimizing CDx utilization, and future data-generation needs • Train medical and field teams on CDx • Support scientific publications • Provide medical review of diagnostic materials • Represent GMA in Alliance partnerships when appropriate • Develop, track, execute, and report goals and objectives • Support budget planning and management • Ensure compliant business practices • Report to the Vice President, Global Medical Affairs, Solid Tumors • Collaborate with global medical affairs, clinical development, program leadership, biometrics, clinical operations, and translational research

🎯 Requirements

• Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology • Extensive pharma/biotech experience in solid tumors • 8+ years of experience within a biotech/pharmaceutical company • Clinical solid tumor oncology experience • Former CDx medical experience is mandatory • Previous Medical Affairs experience in a CDx role strongly preferred • Expert understanding of biomarker incorporation and CDx development in global clinical studies • Deep understanding of LDTs and data generation supporting CDx launch and companion-drug utilization • Knowledge of GCP and ICH Guidelines • Flexibility to work with colleagues in a global setting • Ability to travel approximately 25% • Experience building, managing, and developing individuals and teams preferred • Experience developing and supporting SOPs and policies • Knowledge of industry-standard Clinical Development IT solutions • Executive presence and ability to influence and lead • Exceptional cross-functional collaboration • Impactful written and verbal scientific communication • Problem-solving and risk-mitigation skills

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits

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