Director, Clinical Management – Early Phase, Rare/Specialty Disease

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $186 489 - $278 875 / an

⏰ Temps Plein

🔴 Expert

👨‍⚕️ Directeur Médical

👻 Score fantôme 25%

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

• Develop and oversee the operational strategy and objectives of Global Clinical Development Plans • Plan, execute, and complete clinical programs according to regulations, ICH Guidelines, GCP, and Otsuka SOPs within timelines and budget • Represent Clinical Management in Clinical Development Plan, timeline, and budget development for Business Development opportunities • Develop and apply program-specific standards across studies • Contribute to final analysis, interpretation, clinical trial reports, publications, and presentations • Develop program-level financial estimates and contribute to the MLTP • Lead program-level teams and represent Clinical Management in cross-functional meetings • Prepare and defend clinical program documents, regulatory submissions, and Health Authority briefing materials • Lead clinical sections of regulatory documents and inspection-readiness programs • Build scientific partnerships with key advisors and lead advisory boards, committees, and meetings • Support program-level HEOR strategy and endpoint development • Coordinate with Medical Affairs/PBS on medical information requests, public disclosure, and publication strategies • Represent assigned programs to senior management and disseminate information and tasks to team members • Participate in ESP partnership governance and alliance management • Assist with portfolio-level resource planning • Provide direction, training, and support to Clinical Management personnel • Review clinical trial data for integrity, trends, and consistency • Plan and conduct inspection-readiness activities • Participate in program-level risk mitigation and departmental, cross-functional, ESP, and corporate initiatives • Lead or contribute to standardization and continuous-improvement efforts • Coordinate onboarding and training, ensure compliance and access to required resources, set performance expectations, and provide feedback when supervising staff • Perform other assigned duties

🎯 Exigences

• Comprehensive knowledge of clinical operations, drug development processes, SOPs, and GCP/ICH regulations • Thorough knowledge of CROs, outsourcing, and evaluating vendor work against Statements of Work (SOW) • Advanced understanding of drug development principles and clinical trial implementation and management • Strong knowledge of global regulatory requirements, compliance, biostatistics, data management, and medical writing • Strong communication, organization, planning, analytical, problem-solving, and people-management skills • Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook • Good understanding of clinical trial software such as eCRFs, IRT, and CTMS • Ability to travel up to 25% • Bachelor’s Degree • Minimum 14 years of applicable pharmaceutical industry experience, including 10 years of clinical trial management experience • Previous supervisory 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