Principal Preclinical Scientist

at  Johnson Johnson

DIVERSITY, EQUITY & INCLUSION:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

JOB SUMMARY:

CERENOVUS a Johnson & Johnson company is recruiting for a Principal Preclinical Scientist, in Galway Ireland. The role works collaboratively with R&D, NTI, Regulatory, Strategic Marketing, and Quality to be a leading partner in developing and performing preclinical activities (both animal and in-vitro) to generate evidence for regulatory and clinical acceptance as well as for competitive claims for launch. The role has overall responsibility for animal experiments as the study sponsor representative, and accountable for ‘test-to-fail’ bench testing at any phase of development. Serve as primary facilitator and provide subject matter expertise for additional testing required to support the regulatory challenges of various countries or creation of marketing claims.

WE WOULD LOVE TO HEAR FROM YOU, IF YOU HAVE THE FOLLOWING ESSENTIAL REQUIREMENTS:

• Honours degree in Biomedical Engineering, Biological Sciences, or related medical / scientific field.
• A minimum of 6-10 years’ experience in experimental design within the medical device industry.
• Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.
• Data review and statistical methods skills (Minitab).
• Strong work ethic, creative problem solving, capable of working on own initiative.
• Excellent writing, presentation, and verbal communication skills essential.

ROLE: PRINCIPAL PRECLINICAL SCIENTIST

Location: Ballybrit, Galway
Reports to: Medical Director

LIVE OUR CREDO & PURSUE OUR PURPOSE:

As part of the Johnson & Johnson family of companies, Our Purpose is ‘We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.’ We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.

THE RESPONSIBILITIES AND THE IMPACT YOU WILL HAVE:

• Acquire an in-depth knowledge of current products in development from a technical and usability point of view: design, materials, performances, manufacturing process, clinical workflow.
• Serve as study sponsor representative for animal experiments (including feasibility studies, GLP studies), and accountable for concept to completion of the studies, including defining the model requirements, developing protocols and reports, and presenting to First in Human Committee.
• Evaluate new and current animal labs, become point of contact for logistics and communication.
• Identify and contract neuro-interventionalists with animal intervention background to perform procedures.
• In collaboration with Regulatory, develop and maintain an inventory of Notified Body requirements and responses over the years for animal testing.
• Create a ‘test-to-fail’ strategy to conduct bench testing on products in development to characterise their limits from a usability point of view, using in-house physicians and engineers to perform the testing.
• Effectively work with NTI, our in-house advanced science and modelling group, to coordinate and utilise the NTI lab, models and technologies for related bench testing, and provide input for improvement.
• Develop a mechanism to receive all requests for preclinical testing involved in characterising the limits of a product in development, generating evidence for additional regulatory questions beyond the initial launch in primary country, or for marketing claims to show competitive advantage for products in development or already launched.
• Develop and implement highly complex experiments and responsible for protocols, reports, and presentations to address the research or regulatory questions collaborating with R&D, NTI, Quality, and Regulatory for all animal experiments and relevant bench studies.
• Ensure documentation to appropriate standards and responsible for managing the documents through the Quality System.
• Participate in new product development as a core team member representing preclinical strategy.
• As a core team member and subject matter expert, provide input on study designs and interpretations during the product development cycle based on the Target Product Profile (TPP).
• Evaluate the appropriateness of questions in the voice of customer (VOC) and interpret their answers for the benefit of the team.
• Identify and manage of key preclinical risks throughout the product lifecycle.
• Effectively collaborate with external collaborators, such as academic, Contract Research Organizations (CRO), and biotech partners.
• Other duties as assigned or required.