Senior Director, Quantitative Pharmacology

🕒 il y a 26 jours

🇺🇸 États-Unis – Télétravail

💵 $230 720 - $345 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 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 clinical pharmacology activities and deliverables across all stages of clinical development • Support the Head of Quantitative Pharmacology in managing and growing the functional team • Mentor and train junior scientists and develop clinical pharmacology talent • Oversee pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory submission deliverables • Review and approve Clinical Pharmacology reports and analyses • Oversee clinical pharmacology strategy, including dose finding, dose optimization, exposure-response, and pediatric development • Serve as Clinical Pharmacology Lead on early- and late-stage development teams • Provide data-driven plans and communicate results and strategy to development teams • Coordinate clinical pharmacology interactions with toxicology, DMPK, bioanalytical, biomarker, pharmacometrics, statistics, clinical, regulatory, ADME, and CMC functions • Review business development opportunities and make go/no-go recommendations for QTR • Help set department strategy, growth, and cross-functional alignment • Lead clinical pharmacology strategy and integrate it into clinical development plans for small- and large-molecule drugs • Lead development and approval of clinical pharmacology sections for regulatory filings • Support MIDD strategies and PK/PK/PD modeling analyses for dose selection and efficacy and safety assessments • Support biomarker development and incorporation into early-phase studies • Use innovative data analysis methods to optimize doses, dosage regimens, and study designs • Review and approve healthy-subject clinical study designs and protocols • Work with formulation, biomarker, and bioanalytical teams on formulation development, assay development, sample management, PGx, and biomarker strategy

🎯 Exigences

• PhD in Clinical Pharmacology or a related area such as pharmacokinetics, pharmacology, or pharmaceutics • Minimum of 12 years of experience in these areas • Extensive experience developing and executing clinical pharmacology strategies for early- through late-stage programs, including registrational support • In-depth knowledge of early-phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarkers, and bioanalytical assays for small molecules and monoclonal antibodies • Hands-on experience in PK and PK/PD data analysis and Phoenix NLME • Excellent working knowledge of Phase I clinical operations, drug development principles, multi-region regulatory requirements, and PK/PD analysis • Strong working knowledge of formulation development and clinical development • Current awareness of developments in clinical pharmacology, pharmacometrics, and guidance documents • Ability to apply scientific knowledge to identify core problems, perform insightful analysis, and solve problems effectively • Strong leadership experience related to clinical pharmacology • Strong organizational skills • Strong communication skills • Flexibility to react rapidly to changing situations and environments • Willingness to travel 20% • Experience in early-phase clinical protocol development is a plus

🏖️ 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 • Incentive opportunity