Director of Clinical Operation

Predicine is a molecular insight company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring. Our biology-oriented approach to analyzing genomics is advancing the understanding of tumor mutational landscape. We are applying our expertise in genomic profiling to identify elusive cancer-related genetic changes and new biomarker targets across many cancer types. Our advanced cancer genome analysis helps researchers and biopharmaceutical partners accelerate new precision medicine development.
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 !
The* Director of Clinical Operation* reports to the Head of Clinical Development and is 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.
What you will 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 and provide over arching strategic direction.

Requirements

• Bachelor’s degree in biology or healthcare field(s). Advanced degree (i.e. M.S.) is preferred but not required.
• 15 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 hiring and managing a team of 2-4 CTA’s preferred.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan
• Paid Time Off
• Annual Bonus

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 laws.

Job Type: Full-time