Associate Director, Quantitative Pharmacology, Clinical Pharmacology

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $169 222 - $253 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 1%

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.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

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

• Provide clinical pharmacology input across all phases of small- and large-molecule drug development across multiple therapeutic areas • Support clinical pharmacology activities related to pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory submissions • Support clinical study design, protocol development, study execution, reporting, and data interpretation • Serve as clinical pharmacology lead on cross-functional project teams • Support model-based drug development strategies • Conduct translational or clinical PK and PK/PD data plotting and analyses, including NCA, correlation, exposure-response, and meta-analysis • Work with pharmacometrics teams on PK, PK/PD, and exposure-response analysis and reporting • Author clinical pharmacology sections for regulatory filings, including annual reports, investigator brochures, IND/NDA applications, and pediatric development plans • Author scientific manuscripts and other publications • Collaborate with non-clinical, bioanalytical, formulation development, early development, business development, and external collaborator teams • Support assay development, sample management, pharmacogenomics, and biomarker development • Support formulation development, dissolution testing, IVIVC, in vivo PK studies, and biowaivers • Manage project budgets, outsourced PK and PK/PD analyses, contract requisitions, statements of work, and invoice approvals • Participate in pharmacometrics strategy planning and modeling and simulation activities • Assess and lead development and selection of pre-IND and early-phase assets

🎯 Exigences

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry • Hands-on experience in PK and PK/PD analysis using software such as Phoenix NLME and R • Excellent working knowledge of Phase I clinical operations, drug development, multi-region regulatory requirements, and PK/PD analysis • Strong working knowledge of formulation development, drug development, and clinical development • Current awareness of developments in clinical pharmacology, pharmacometrics, and guidance documents • Ability to apply scientific knowledge to drug development, identify core problems, perform insightful analysis, and solve problems effectively • Strong hands-on clinical pharmacology experience • Strong organizational skills • Strong verbal and written communication skills • Flexibility to react rapidly to changing situations and environments • PhD, PharmD, or MS in Clinical Pharmacology or a related area such as Biomedicine, Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, or Pharmaceutics • Minimum 4 years of industry experience in the specified areas • Experience in population PK and PK/PD modeling and statistical models is a plus • Ability to travel 15%

🏖️ Avantages

• Incentive opportunity • Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death & 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