Senior Director, Clinical Pharmacology

🕒 Maio 2

🏄 California – Remoto

🏄 California – Remote

💵 $238.000 - $297.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Crinetics Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Crinetics Pharmaceuticals é uma empresa de biotecnologia que desenvolve terapias inovadoras para doenças endócrinas. A empresa está focada em atender necessidades médicas não atendidas, criando tratamentos para condições como acromegalia, síndrome carcinoide, síndrome de Cushing dependente de ACTH, hiperplasia adrenal congênita e outros distúrbios endócrinos. A Crinetics está comprometida em melhorar a qualidade de vida dos pacientes através de ciência de ponta e ensaios clínicos robustos. Seu pipeline inclui candidatos promissores como paltusotina, que foi aceita pelo Food and Drug Administration dos EUA para o tratamento de pacientes adultos com acromegalia. A empresa colabora com profissionais de saúde e partes interessadas para garantir que suas terapias abordem problemas reais de forma eficaz e agreguem valor para os investidores ao entrar em nichos de mercado com necessidades significativas.

Descrição

• Develop clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and the US/international regulatory guidance/guideline of small molecule therapeutics • Collaborate with DMPK, clinical research, and CMC teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label • Determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies • provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis. • Participate in the selection of Phase 1 CROs for clinical pharmacology studies • Accountable and responsible for the analysis and interpretation of PK and PK/PD data • Participate in preparation of clinical study protocol and report • Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.) • Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to insure integration of modern clinical pharmacology principles into project plans and study design • Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert • Focus on both immediate/short-term (<2 Years) and long range (5 years) strategic planning to determine function objectives • Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning.

🎯 Requisitos

• Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles • 10+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysis • minimum of 10 years of experience in a supervisory role • 13 years of overall professional experience is required • Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects • Demonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds • Expertise/experience in multiple clinical pharmacology areas is preferred - FIH and/or Ph II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect, exposure-QTc assessments, special population, and radiolabeled mass balance studies • Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings • Experience in working in a cross functional team/matrix environment with strong vendor management skills • Competent in the use of PK and PK/PD Modeling software tools such as Phoenix • Strong written, presentation, and verbal communication skills • Critical thinker with strong problem-solving skills • Ability to influence business leaders at all levels.

🏖️ Benefícios

• discretionary annual target bonus • stock options • ESPP • 401k match • top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown