Senior Director, Clinical Pharmacology

🕒 vor 1 Monat

🏄 California – Remote

🏄 California – Remote

💵 $238.000 - $297.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

Jetzt Bewerben

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Crinetics Pharmaceuticals

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2015

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals ist ein Biotechnologieunternehmen, das innovative Therapien für endokrine Erkrankungen entwickelt. Das Unternehmen konzentriert sich darauf, ungedeckte medizinische Bedürfnisse zu adressieren, indem es Behandlungen für Zustände wie Akromegalie, Karzinoid-Syndrom, ACTH-abhängiges Cushing-Syndrom, kongenitale Nebennierenhyperplasie und andere endokrine Störungen schafft. Crinetics engagiert sich für die Verbesserung der Lebensqualität von Patienten durch modernste Wissenschaft und robuste klinische Studien. Ihre Pipeline umfasst vielversprechende Kandidaten wie Paltusotin, das von der US-amerikanischen Food and Drug Administration für die Behandlung von erwachsenen Patienten mit Akromegalie akzeptiert wurde. Das Unternehmen arbeitet mit Leistungserbringern im Gesundheitswesen und Stakeholdern zusammen, um sicherzustellen, dass ihre Therapien reale Probleme effektiv angehen und für Investoren Wert schaffen, indem sie Marktnischen mit signifikanten Bedürfnissen betreten.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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