Vice President, Drug Safety/Pharmacovigilance

🕒 February 12

🏄 California – Remote

🏄 California – Remote

💵 $339k - $424k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

📋 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.

🎯 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