Senior Director, Global Clinical Development

🕒 il y a 16 jours

🇺🇸 États-Unis – Télétravail

💵 $230 720 - $345 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

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

• Lead clinical development strategy and execution for assigned programs from proof of concept through late-stage trials and regulatory submissions • Provide medical and scientific leadership to cross-functional study teams • Ensure high-quality clinical trial design, conduct, and data interpretation • Serve as medical lead and subject matter expert for assigned indications • Ensure trials comply with GCP, regulatory requirements, and internal processes • Lead and contribute to clinical sections of INDs, IBs, clinical study reports, and NDAs/BLAs • Collaborate with regulatory affairs on interactions with global health authorities • Provide strategic and medical oversight to vendor and CRO relationships and governance committees • Lead clinical discussions with KOLs and advisory boards • Develop medical monitoring plans and asset development plans • Contribute to publication plans and review scientific manuscripts • Mentor and provide leadership to junior team members • Support business development through medical due diligence and evaluation of external opportunities • Contribute to corporate continuous process improvement initiatives

🎯 Exigences

• M.D. or D.O., preferably with an immunology, rheumatology, or dermatology background • Management experience, direct or indirect • Minimum of five years of clinical research experience post academia as a general guideline • Experience in the pharmaceutical industry, clinical practice, and/or academic translational clinical research • Thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines, including biostatistics, data management, and medical writing • Advanced understanding of clinical medicine and science • Advanced understanding of drug development principles and clinical trial implementation and management • Complete understanding of global regulatory requirements • Working knowledge of marketing and commercialization • Understanding of corporate goals and basic business principles • Demonstrated experience across developmental phases, including preclinical or in-licensing evaluation, early clinical safety and proof of concept, global registration trials, and late-stage life-cycle management • Demonstrated experience leading clinical aspects of regulatory interactions • Ability to work across therapeutic areas and stages of clinical development • Demonstrated ability to manage and motivate clinical team members, internal staff, and external investigators/consultants • Strong communication and presentation skills • Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook • Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing • Travel approximately 30–35%

🏖️ 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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