Associate Director, Clinical Pharmacology

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Enliven Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Enliven Therapeutics é uma empresa dedicada ao desenvolvimento de soluções inovadoras para o tratamento do câncer. Focam na criação de inibidores de quinase de pequenas moléculas, projetados para melhorar a eficácia, segurança e conveniência para o paciente. Com programas que visam alvos como BCR-ABL, HER2 e vias adicionais, a Enliven Therapeutics busca aprimorar a precisão e a seletividade dos tratamentos contra o câncer, combater a resistência e abordar metástases cerebrais. A empresa se orgulha de ter uma equipe de desenvolvedores de medicamentos experientes e visa ajudar pacientes com câncer a viverem vidas mais longas e melhores.

Descrição

• Responsible for the preparation of the clinical pharmacology sections of early and late-stage clinical protocols • Contribute to the preparation of the IND, IB and IMPD documents • Be able to conduct noncompartmental PK analysis based on preliminary data using standard industry data analysis software • Contribute to the design of early phase clinical trials (FIH to POC) • Contract and monitor CRO for clinical pharmacology projects, such as popPKPD analysis, clinical pharmacology studies • Represents the Clin Pharm function in project teams • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions.

🎯 Requisitos

• PhD with More than 3 years (or MS with more than 6 years) of industry experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry. • Experience with small molecule drug development is required. • Knowledge of oncology drug development is a plus. • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data • Knowledge of general regulatory process and experience in writing Clin Pharm documents to support IND, EOP1, EOP2, or pre-BLA/NDA meetings with the FDA, EMA and other regulatory agencies • Excellent written and oral communication skills including good presentation skills • Hands-on modeling experience with PBPK modeling platforms is preferable.

🏖️ Benefícios

• Benefits are included • Other incentives such as bonus and equity may be provided