Executive Director, Global Medical Affairs, Companion Diagnostic Lead

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $296 600 - $376 600 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 21%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of BeOne Medicines

BeOne Medicines

10 000+ employés

Fondée en 2010

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines est une entreprise mondiale d’oncologie dont le siège est en Suisse. Elle découvre et développe des traitements innovants, plus abordables et plus accessibles aux patients atteints de cancer dans le monde entier. Avec un portefeuille couvrant l’hématologie et les tumeurs solides, BeOne accélère le développement de son pipeline diversifié de nouvelles thérapies grâce à ses capacités internes et à ses collaborations. Forte d’une équipe mondiale en croissance de plus de 11 000 collaborateurs présents sur six continents, l’entreprise s’engage à améliorer radicalement l’accès aux médicaments pour un bien plus grand nombre de patients qui en ont besoin.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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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