Crinetics Pharmaceuticals

Crinetics Pharmaceuticals is dedicated to advancing treatments for rare endocrine diseases, aiming to enhance patients' lives by developing innovative therapies

Vice President, Drug Safety/Pharmacovigilance

Vice PresidentVice PresidentFull TimeRemoteLeadCompany Site

Location

California

Posted

35 days ago

Salary

$339K - $424K / year

Seniority

Lead

Postgraduate Degree13 yrs expEnglishGoogle Cloud Platform

Job Description

• 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.

Job Requirements

  • 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.

Benefits

  • 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

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