Director, Global Clinical Development

🕒 Agosto 20

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $209.599 - $313.375 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 3%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• Design and oversee clinical research programs and protocols for OPDC products under good clinical practices • Evaluate and clinically develop CNS and Digital Medicine products at different stages for a global healthcare market • Consult with patients or representatives, clinical, regulatory, and scientific leaders to optimize trial objectives, designs, and protocols • Serve as an internal medical/scientific consultant to health economics, medical affairs, marketing, regulatory, statistical, and research project teams, as well as external regulatory agencies • Author global development and commercialization plan strategies • Oversee trials assessing clinical safety, efficacy, medical usefulness, and product value • Interpret and communicate Phase I–IV investigation results for new drug preparation • Act as signatory on NDA submissions and clinical study and safety documents • Support product lifecycle management and identify strategic innovations • Provide strategic oversight of vendor and CRO relationships and clinical input to governance committees • Lead and support regulatory filing activities and documents, providing strategic direction and editing • Develop concise, clear, and convincing written and verbal communications

🎯 Requisitos

• M.D. or D.O.; preferably a nephrologist or immunologist • Prior management experience, direct or indirect • Experience in the pharmaceutical industry or academic translational clinical research; typically 3–6 years for Director level depending on experience type • Thorough knowledge of clinical medicine and science management • Ability to communicate effectively in meetings and through written and oral presentations • Facility with Microsoft Word, Excel, PowerPoint, and Outlook • Demonstrated experience leading, managing, and motivating internal staff and external investigators or consultants • Advanced understanding of drug development principles and clinical trial implementation, management, and reporting • Flexibility across therapeutic areas and clinical development stages • Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing • Complete understanding of global regulatory requirements • Working knowledge of health value creation, financial assessment, project planning and budgeting, market research, and commercialization strategies • Dedication to projects and goals in a compliant, regulated, matrixed business setting • Willingness to travel 30% of the time, including weekends, and ability to travel internationally

🏖️ Benefícios

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity