Vice President, Drug Safety/Pharmacovigilance

🕒 Fevereiro 12

🏄 California – Remoto

🏄 California – Remote

💵 $339.000 - $424.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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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

• Design and develop the Global Crinetics Drug Safety and Pharmacovigilance system • Ensure adequate resourcing, efficient and compliant safety reporting • Implement Safety Surveillance Programs • Oversee the safety profiles of Crinetics products • Play a leading role in safety risk management activities • Provide safety support to Clinical Research • Oversee the preparation of new drug application safety updates and investigational new drug safety reports • Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Crinetics departments and external vendors • Ensure study safety objectives are accomplished • Review clinical data from all phases of development and assist in generating study reports and publications • Develop and oversee safety surveillance systems for Crinetics drug candidates and products • Provide coaching and mentoring to direct and indirect reports.

🎯 Requisitos

• MD with a minimum of 13 years of drug safety/PV experience in the biotechnology/pharmaceutical drug industry • A minimum of 14 years in a supervisory role • Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment • Strong project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems • Ability to work independently and collaboratively, prioritizing tasks efficiently and meeting clinical and corporate timelines • Thorough knowledge of clinical medicine, clinical pharmacology, and associated disciplines (e.g., biostatistics, data management, medical writing) • Strong general knowledge of GCP, ICH guidelines and regulatory requirements that apply to clinical drug development • Experience in interacting with the FDA and/or EU regulatory agencies • Thorough understanding of strategic and operational aspects of clinical research and product development • Superior interpersonal skills focusing on collaboration and influencing capabilities.

🏖️ Benefícios

• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans for employees and their families (medical, dental, vision, basic life insurance) • 20 days of PTO • 10 paid holidays • Winter company shutdown