Associate Director, Investigator Initiated Trials

🕒 Março 29

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Responsible for the effective management of all aspects of Investigator-initiated Trials (IITs) including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines • Assist with program management, including use of the BeOne contract system for creating and tracking contracts and report creation through the IIT portal • Support the review process for medical affair studies • Support IIT operations and project management, cross-functional collaborations, process improvement, and vendor management • Act as the Medical Internal Review Committee (MIRC) lead • Review submitted proposals and protocols, adjudicate revised proposals and protocols based on MIRC comments • Communicate comments from and the final decision of the MIRC review to the investigator and BeOne field medical team • Assist in study budget coordination with PI and BeOne • Support monthly study status report(s) and maintaining updated study information in the IIT portal • Interface with the Accounting Departments to manage POs, record and reconcile all payment information and invoices

🎯 Requisitos

• BA/BS Degree is required • Advanced degree (MD/PharmD, MS) is preferred • MD/PharmD with 4 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO • Masters Degree with 6 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO • Bachelors Degree with 8 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO • Strong project management skills • Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and within multi-disciplinary teams

🏖️ Benefícios

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