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 - Clinical Data Management
February 12
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
• responsible for all clinical data management activities and deliverables for assigned studies • supervise junior data manager(s) • vendor management, budget and contract review, negotiations and management • oversight for all data management deliverables and timelines from study start-up through close-out • partner with other functional groups and external vendors • core member of the Data Management Standard Committee • manage assigned studies/projects and make expert recommendations/decisions
🎯 Requirements
• MS/BS in life sciences or related field • 8+ years of direct data management experience (10 years with a Bachelor’s) • at least 7 years managing direct reports • in-depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry • in-depth knowledge and experiences in clinical trials in Oncology and/or Rare Disease in Endocrine Disorder • strong project management skills and experience working with CROs/vendors • demonstrated competency in Standardization and Change Control processes • demonstrated leadership quality and superior organizational/interpersonal skills • detail-oriented with excellent communication skills • highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance • knowledgeable of GCP, ICH, and other regional regulations • experience with clinical data lifecycle from database set-up to archiving • knowledge of current technologies in clinical trial data collection and data management systems
🏖️ Benefits
• discretionary annual target bonus • stock options • ESPP • 401k match • health insurance plans for employees and their families (medical, dental, vision and basic life insurance) • 20 days of PTO • 10 paid holidays • winter company shutdown
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