Crinetics Pharmaceuticals
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.
Drug Discovery • Endocrinology • RareDisease • Biotech
Associate Director - Risk Management Coordination
March 18
Crinetics Pharmaceuticals
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.
Drug Discovery • Endocrinology • RareDisease • Biotech
📋 Description
• Lead Risk Management study activities in Clinical Operations • Represent Clinical Operations in cross-functional discussions • Lead or participate in discussions with CROs on RMC activities • Author or review processes and tools related to Risk Management • Support selection and implementation of Clinical Operations RBQM technology • Partner with CROs on execution of RBM components • Create internal RBM strategies for Clinical Operations • Develop KRIs related to Site Health/Performance Monitoring • Contribute to robust internal processes complementing RBM strategies • Act as SME on study teams for Clinical Operations RBQM activities • Provide training and change management to accelerate RBQM adoption
🎯 Requirements
• Bachelor’s degree in health sciences or related discipline • Minimum of 12 years of experience in biotechnology/pharmaceutical industry • At least 5 years of direct experience in Clinical Operations and Risk-based Quality Management • Experience in all stages of drug development and clinical trial processes • Deep understanding of Good Clinical Practices, ICH Guidelines, and regulatory requirements • Highly advanced knowledge of ICH E6r2 and risk-based requirements • Experience with clinical trial systems such as eTMF and CTMS • Experience with RBQM technology preferred • Strong knowledge of industry RBQM methodologies like Transcelerate and/or WCG Avoca • Strong interpersonal, communication, and negotiation skills • Proficiency in Microsoft Office tools. • Understanding of latest trends in RBQM
🏖️ Benefits
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Medical, dental, and vision insurance • Basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown
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