Study Director - Preclinical Surgical

Company: North American Science Associates, Inc.
Location: Minneapolis
Posted on: May 28, 2023

Job Description:

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.
  Job Description:
  --- Assists in the coordination of study conduct tasks from study initiation to study completion.
  --- Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
  --- Performs project in compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
  --- Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable.
  --- Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed.
  --- May need to participate in study specific procedures.
  --- Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report.
  --- Assures that all data including unanticipated responses are accurately recorded, verified and organized.
  --- May need to ensure that study records for GLP studies are archived upon completion of the study.
  --- May need to interact with regulatory bodies (i.e. FDA, NMPA, ANSM, etc)
  --- Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary.
  --- Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
  --- Participates in client discussions regarding study design when needed.
  --- Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
  --- Establishes and ensures schedule, budget and quality commitments are met for the client.
  --- Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
  --- Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
  --- Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
  --- Assists with departmental training as needed.
  --- Other duties as assigned.
  Qualifications & Technical Competencies:
  NAMSA is a rapidly growing, global organization. We are always looking to connect with top talent in our industry. If you are interested in being considered for this FUTURE opening in meaningful and diverse work, apply TODAY for immediate review.
  The ideal candidate has recent industry experience in managing large animal medical device studies, analyzing & interpreting study results, project management, has performed surgeries, and interested in learning more about being a study director at NAMSA in any of the below expert levels.
  Primary Duties and Responsibilities:
  -- Associate Study Director (ASD)
  --- Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
  --- Understands the intended clinical use of the test article being evaluated.
  --- Handles challenging situations and knows when to call-in help.
  --- Participates in study specific procedures as required.
  --- Performs project in compliance with regulations.
  --- Manages cross-functional projects effectively.
  --- Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable.
  --- Assist Study Director(s) with protocol and report development.
  --- Other duties as assigned.
  -- Study Director
  In addition to the items listed above:
  --- Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
  --- Participates in client discussions regarding study design when needed.
  --- Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
  --- Establishes and ensures schedule, budget and quality commitments are met for the client.
  --- Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
  --- Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
  --- Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
  --- Assists with departmental training as needed.
  --- Other duties as assigned.
  -- Senior Study Director
  In addition to the items listed above:
  --- Develops and leads moderately complex study design and protocols.
  --- Participates in client discussions regarding study design and product development goals including regulatory submission pathway.
  --- Prepares publications and/or presentations and participates in conferences, webinars, or other industry venues.
  --- Provides mentoring and training to other Study Directors.
  --- Other duties as assigned.
  -- Principal Study Director
  In addition to the items listed above:
  --- Participates in client discussions regarding study design and product development goals including regulatory submission pathway.
  --- Develops and leads complex study design and protocols.
  --- Performs technical review and approval of specialized protocols and reports
  --- Identifies and develops ways to improve the technical/scientific skills and professional competency of SDs
  --- Speaks at conferences, webinars, or other marketing venues.
  --- Other duties as assigned.
  Role-Specific Duties and Responsibilities
  --- Serves as the Study Director for GLP and non-GLP preclinical studies and is the single point of control for multidisciplinary preclinical projects (In Vivo and In Vitro Biocompatibility, Chemistry, Microbiology, Surgical).
  --- Develops study design and protocol as well as specific data collection forms.
  --- Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary.
  --- Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report.
  --- Coordinates and manages client expectations.
  --- Interacts with regulatory bodies, including but not limited to FDA.
  --- Travels as needed to manage client expectations.
  Sales/Marketing Duties and Responsibilities
  --- Assist in study design and provides scope of project and relevant information to support the creation of proposals
  --- Participates in meetings with prospective and current clients.
  --- Identifies opportunities to bring in new projects/clients.
  --- Offers opportunities to clients for expansion of MRO services to be provided by NAMSA.
  Qualifications and Skills:
  -- Associate Study Director
  --- Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with 1-3 years of related laboratory experience or 5 years relevant experience without the degree.
  --- Scientific certification a plus (ie. ALAAS or ALAT)
  --- Fluency in English and local language, if different, required.
  --- Advanced degree may be required for EMEA and APAC locations.
  -- Study Director
  --- Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with 2- 4 years related laboratory experience or 8 years relevant laboratory experience without a degree.
  --- Master's degree/PhD with a minimum of 1 year of relevant laboratory experience.
  --- Advanced degree required for EMEA and APAC locations.
  --- Previous study director experience preferred
  --- Project management experience and regulatory interface preferred
  --- Scientific certification a plus (ie. ALAAS or ALAT)
  --- Fluency in English and local language, if different, required.
  --Senior Study Director
  --- Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with 4 - 6 years related GLP laboratory experience or 10 years relevant experience without a degree. Three years previous study directing experience preferred.
  --- Master's degree/PhD with a minimum of 3 year of related GLP laboratory experience. Three years previous study directing experience preferred.
  --- Advanced degree required for EMEA and APAC locations.
  --- Project management experience and regulatory interface preferred
  --- AALAS certification recommended.
  --- Fluency in English and local language, if different, required.
  --Principal Study Director
  --- Bachelor's degree in a scientific discipline with a minimum of 8 years of related GLP laboratory experience. Minimum of 6 years previous study directing experience.
  --- Master's degree with a minimum of 6 years of related GLP laboratory experience. Must include at least 4 years of previous study director experience and/or
  --- PhD with a minimum of 5 years of related GLP laboratory experience. Must include at least 3 years of previous study director experience.
  --- Advanced degree required for EMEA and APAC locations.
  --- Project management experience and regulatory interface required.
  --- DABT recommended.
  --- Fluency in English and local language, if different, required.
  Technical Competencies:
  --- Knowledge of Good Laboratory Practices for Nonclinical Laboratory Studies (21 CFR Part 58), highly desirable
  --- Knowledge and experience with quality systems
  -- Laboratory and Surgical experience required in some roles
  --- Familiarity with medical device development process from pre-clinical to commercialization
  --- Awareness of applicable guidelines and regulations including, but not limited to USDA, USP, FDA, ISO, MHLW
  --- Demonstrated knowledge of a laboratory, analysis of scientific data, technical writing, organizational and communication skills.
  Working Conditions
  --- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  --- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kgs). Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
  --- Extensive use of a computer keyboard.
  Working Conditions:
  --- While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens.
  --- The noise level in the work environment is usually moderate.
  --- While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds.
  --- Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.

Keywords: North American Science Associates, Inc., Minneapolis , Study Director - Preclinical Surgical, Executive , Minneapolis, Minnesota