Job Description

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

Position Title: Biocompatibility & Toxicology Study Director

Location: Onsite at Canyon Labs in Rush, New York

Schedule: Monday – Friday 8:00AM – 5:00PM

Salary Range: $75,000 - $110,000

Position Overview

The Study Director is responsible for managing the design, conduct and reporting of studies, meeting all scientific, regulatory and client requirements. The Study Director is the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the study team and clients is a key success factor.

Position Responsibilities

The primary responsibilities include:

• Serve as a Study Director/Project Leader for Medical Device & Pharma studies (GLP & Non-GLP)
• Prepare study designs, protocols, and reports
• Schedule studies/coordinate study activities with study personnel, Quality Assurance and clients
• Communicate and coordinate with clients regarding study design, planning and execution
• Manage subcontractors and outside vendors supporting multi-site studies
• Review and approve raw data and reports
• Support in life activities
• Participate in regulatory and customer audits and ensures compliance within studies
• Serve as subject matter expert and process expert for drug safety and ISO 10993 studies
• Develop, deploy and sustain best practices
• Leverage broad technical expertise and process knowledge to drive Toxicology department and operational excellence
• Review data/study management, assess impact of study changes
• Serve as preclinical representative for client project teams as needed
• Onboard offerings including development and validation
• Managerial duties:
• May directly supervise employees at Study Director, Scientist, and technician levels.
• Provide training/guidance for scientific & technical staff, serve as mentor
• Directing intermediate and complex level studies in design and scope.

Additional responsibilities:

• May participate in scientific conferences
• Participate in cross-functional and company-wide teams
• May participate in regulatory and standards committees
• May participate in leadership roles for external committees

Position Qualifications:

• PhD or equivalent preferred, or MSc/BSc degree in an appropriate scientific discipline with drug development experience.
• Previous study design, data interpretation and report writing experience
• Knowledge of requirements for working within a GLP and GMP (as appropriate) environment
• Experience in the medical device/drug safety process, knowledge of regulatory requirements and related scientific techniques
• Experience of client management and technical expertise in the relevant business line.
• Fully competent in technical roles supporting study director.

Canyon Labs offers several benefits as part of your total compensation, including but not limited to:

• Paid Time Off, Sick Time, and Paid Holidays
• Medical, Dental and Vision Insurance
• Long term disability insurance, life insurance
• 401(k) with company match up to 4%

At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.

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