Senior Manager, Clinical Management – Early Phase, Immunology/Auto-immune

🔥 15 horas atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $150.034 - $224.250 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 0%

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

• Oversee and manage early-phase (P1–2a) clinical studies • Plan, execute, and complete clinical trials according to applicable regulations, ICH/GCP, and Otsuka SOPs • Contribute to development and review of clinical study documents, protocols, and informed consent forms • Provide input into identification, evaluation, and selection of CROs, outside vendors, and investigative sites • Lead and guide the clinical team to complete study activities compliantly • Communicate and coordinate project activities and progress across cross-functional departments • Provide management with updates on scope, schedule, and resources • Participate in forecasting study expenditures and resourcing needs • Ensure study budgets and expenses remain within forecast and communicate variances • Establish communication flows with CROs and investigative sites to maximize protocol compliance • Oversee ESP day-to-day trial operations • Review clinical trial data for data integrity, trends, and consistency • Support inspection readiness and ensure TMF completeness, timeliness, and quality • Represent Clinical Management in protocol reviews and departmental or cross-functional initiatives • Participate in program- and study-level risk mitigation activities • Lead or contribute to standardization and continuous improvement efforts • Coordinate training and onboarding of new employees when assigned • Set performance expectations and development plans and provide employee feedback when assigned • Perform other assigned duties

🎯 Requisitos

• Ability to oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications • Comprehensive knowledge of clinical operations, drug development processes, project team roles and responsibilities, SOPs, and GCP/ICH regulations • Thorough knowledge of CROs, outsourcing, and evaluating work against vendor Statements of Work (SOW) • Strong understanding of the clinical and scientific basis for the assigned clinical program, with ability to translate that knowledge into operational management • Strong understanding of global regulatory requirements • Strong communication, organization, planning, analytical, problem-solving, and people management skills • Demonstrated experience with Microsoft programs including Word, Excel, PowerPoint, and Outlook • Good understanding of clinical trial software including eCRFs, IRT, and CTMS • Ability to travel up to 25% • Bachelor’s Degree or Registered Nurse (RN) • Minimum of 10 years of industry experience, including seven years in clinical trial management experience

🏖️ 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