Associate Director - Clinical Trial Operations

March 18

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Crinetics Pharmaceuticals

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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

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Directs the planning, execution, monitoring, and completion of clinical development programs or projects • Interacts with CROs, external investigators, and internal staff across various departments • Serves as a member of the Clinical Operations management team • Plans and executes clinical trials in collaboration with scientific and medical experts • Manages CROs to execute clinical trials within budget and timelines • Identifies budget, timeline, and quality risks and communicates with stakeholders • Assists in preparation and review of regulatory filings and submissions. • Collaborates with senior management to ensure consistency across clinical trial portfolio • Leads, manages, develops, and evaluates direct reports and employees

🎯 Requirements

• Minimum BS in biological sciences or related discipline with at least 10 years of related experience • Minimum of five (5) years of direct clinical study management experience required • A minimum of seven (7) prior experience managing others • Prior experience managing CROs and other external service providers on a global scale is a must • Knowledge of GCPs, ICH guidelines and FDA regulations; familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus • Prior experience with the preparation of NDAs and MAAs and other regulatory documents is highly desirable • Excellent writing skills as they relate to preparation of regulatory documents • Excellent interpersonal skills with strong oral/written communication and presentation skills • Experience in managing external service providers and consultants • Demonstration of a broad-based and cross-functional understanding of the drug development process • Excellent time management skills and ability to mentor junior staff in time management

🏖️ Benefits

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