Nonclinical Study Director

About the Role: We are looking for a Non Clinical Study Director to join our Bioscience team to drive the development, organization, execution, and documentation of nonclinical studies performed for the evaluation of medical technologies.
This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
Responsibilities:

• Collaborate with Biosciences subject matter experts to develop scientifically rigorous nonclinical studies
• Drive coordination and execution of nonclinical studies, including protocol development, navigating the protocol approval process, device procurement, data collection and analysis, study documentation, and reporting of results
• Support nonclinical testing aspects of regulatory submissions with key stakeholders
• Support the education of associates on the appropriate utilization of animal models (e.g., model limitations, clinical relevance, data collection and interpretation, scientific application, and design)
• Partner with Biosciences teams to effectively achieve prioritized needs, while working within operational constraints
• Understand and comply with applicable regulations (e.g., guidance documents, Good Laboratory Practice, Animal Welfare Act) for nonclinical studies
• Maintain compliance with training expectations as required for this position

Required Qualifications:

• Bachelor's degree in Life Sciences, Biomedical Sciences, or Biomedical Engineering
• Minimum 3 year experience in a nonclinical testing laboratory
• Basic understanding of GLP Regulations
• Excellent organization skills
• Strong scientific rigor with ability to critically review literature, analyze data, author scientific documents
• Ability to travel up to 5%

Desired Qualifications:

• Advanced degree in Life Sciences, Biomedical Sciences, Biomedical Engineering or another relevant field
• Experience in open surgical and interventional procedures; experience functioning as a Study Director for nonclinical studies, and/or practical experience conducting GLP compliant nonclinical studies
• Understanding of animal and human anatomy, physiology, pathophysiology and histopathology

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact