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

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $150 034 - $224 250 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Otsuka Pharmaceutical Companies (U.S.)

Site WebLinkedInTous les Emplois

1001 - 5000 employés

💊 Pharmaceutique

🏥 Santé

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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