Job description
Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. www.predicine.com
Are you a results driven subject matter expert looking for a seat at the
table? Join us as the
Director of Clinical Operation reporting to the Head of Clinical Development. You will be responsible for the execution and operation of the company’s global clinical trials, specifically for companion diagnostic (CDx) clinical trials, and activities related to clinical study design, preparation, execution, and operation.
At Predicine, we are passionate about our people, technology, and creating a lasting impact in cancer research. If you enjoy challenges, collaborating with others to solve complex problems, and the chance to see your work impact the millions of lives touched by cancer, we invite you to join us.
What you get to do:
Leads and manages the operation and execution of clinical study process and procedure.- Manages and collaborates with CRO or partner companies for study operation.
- Responsible for communication with clinical sites and sponsors.
- Supports a Dx study protocol preparation and submission to the IRB.
- Supports applications to appropriate regulatory agencies (i.e. Breakthrough Device Designation and PMA).
- Manages study budget, expense, and other financial aspects related with clinical studies.
- Supports audits from sponsors or regulatory agencies for clinical studies.
- Manages data collection, transfer, and storage based on company policy.
- Manages sample collection kit shipping, handling, and tracking.
- Works cross functionally with Quality and Regulatory to support clinical study execution and operation.
Skills /Qualifications/Experience:
Bachelor’s degree in biology or healthcare field(s). Advanced degree (i.e. M.S.) is preferred but not required.- 10+ years of experience in clinical trial management and/or operation preferred.
- CDx study management experience is highly desirable.
- Experience of the liquid biopsy testing or next-generation sequencing (NGS) is desirable.
- Diagnostic IVD experience is preferred.
- Global Pharma clinical trial (>10 countries, >100 clinical sites) operation experience is required.
- CRO management experience is preferred.
- Experience with ISO 13485 and FDA medical device or IVD regulations is desirable.
- Experience and understanding of GCP, GCLP, and other clinical study related regulations and guidelines preferred.
- Excellent communication and interpersonal skills.
- Proven strong problem-solving ability and root cause analysis skills.
- Meticulous approach with close attention to detail.
- Competency in interpersonal skills with diverse workforce. Advanced written and verbal skills.
- Experience managing a team of 2+ CTAs preferred.
Location
This role is required to be onsite in Hayward, CA
We require all Predicine employee’s to be fully vaccinated and provide proof of vaccination on their first day of work. Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal law.
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