Director, Global Clinical Development

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $209 599 - $313 375 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 12%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.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.)

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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

• 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

🎯 Exigences

• 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

🏖️ 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

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