Senior Medical Affairs Operations Manager

🕒 March 12

🏄 California – Remote

🏄 California – Remote

💵 $147k - $184k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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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

• Managing the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies and post-trial access programs • Overseeing the review, monitoring, and adherence to clinical protocols • Providing oversight of clinical affairs programs across all functional areas of the drug development process • Developing the subject recruitment/retention strategy and related initiatives • Overseeing TMF set-up, ongoing quality review, and final reconciliation of study documents • Developing training materials for the program team, investigational sites, and vendors • Collaborating with counsel to negotiate and draft contracts and agreements with CROs/vendors and clinical sites

🎯 Requirements

• Bachelor’s degree required, preferably in a scientific discipline • Minimum of 8 years of prior clinical operations experience managing clinical trials • at least 5 years in a supervisory role • Experience managing clinical studies is preferred • Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, and IRT and EDC systems • Excellent understanding of the drug development process • Strong ability to analyze and generate reports • Understanding of FDA regulatory requirements (i.e. GCPs, CFRs, etc.) • Experience in rare disease and/or oncology is preferred

🏖️ Benefits

• Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown • discretionary annual target bonus • stock options • ESPP • 401k match