Reliant Immune Diagnostics has built a complete in-home diagnostic platform directly for consumers. Individuals can now self-test at home and get immediate treatment without long wait times or late-night trips to the ER. Our products will transform the healthcare delivery model, putting consumers in the driver seat with a safe, accurate, and affordable platform for diagnosis and treatment anytime, anywhere. This is not an easy task, which is why we are expanding our scientific team with bright, fearless, and self-motivated leaders. We’re a fast-moving startup consisting of a passionate group of over 40 physicians, scientists, engineers, and established business leaders who are united by a shared mission to make healthcare a seamless part of our everyday lives.
Reliant Immune Diagnostics is seeking a Senior Scientific Study Manager to work at our Austin, TX campus. Integral to the success of our company will be your ability to show up, take charge, and lead the laboratory, clinical and regulatory documentation components of product development. It will be your job to write protocols, design experiments, perform bench studies, oversee clinical trials, and summarize complex data to ensure successful completion and submission of each FDA application.
Find out more about our company here: reliantid.com
How will you make an impact?
The Senior Scientific Study Manager is responsible for developing IVD products for Reliant. You will lead, direct, and mentor a team of R&D personnel, allocating resources as required. You will act as the technical expert on new product development teams and scientific projects. The position reports to the Chief Operating Officer and will work closely with the Chief Medical Officer, Head of Regulatory Affairs, and Chief Technology Officer.
What will you do?
Coordinate, write, review and execute IVD analytical method validations
Assist in gathering technical information for pre-submission meetings, IDEs, De Novo dossiers, interpretations/assessment of standards/guidance and applicability
Draft and/or evaluate SOPs and Work Instructions, write, review, and assess protocols and reports for suitability for submission to regulatory bodies
Develop next generation IVD sequencing based assays following the Decision to Investigate through Product Commercialization Process (PCP) to Product Release Checkpoint, including involvement in clinical trial planning, site training, and data reviews for necessary regulatory submissions.
Independently and alongside with the Head of Regulatory Affairs, plan, direct and execute product development strategies to meet FDA (510(k) and PMA), CE-IVD, and other regulatory agency requirements. Anticipate potential problems and design preventative solutions. Determine strategic approach to experimental design.
Critically analyze complex data, interpret and integrate experiment results with project and division objectives. Set project directives based on data analysis. Maintain complete and thorough documentation required to meet QSR Design Control, as well as other international standards (e.g. ISO compliance, GLP/GMP requirements, etc.).
Oversee and manage the IVD R&D staff, including hiring, performance management, training and professional development. Provide strategic direction and guidance to Scientists, Research Associates and Engineers in their daily experiments and troubleshooting. Lead team in systematic problem analysis and resolution processes for project advancement. Guide team in matrix environment.
Interface with other departments (i.e., Marketing, Business Development, Regulatory, Technical Service and/or Operations) to coordinate product development and improvement.
Provide guidance to Chief Technology Officer on assay product pipeline and creating technical product advantages versus competitors.
Perform fundamental literature and patent searches related to new product opportunities. Develop alternative strategies as necessary. Recognize opportunities for in-licensing and internal patent development. Prepare patent disclosures and support the legal department in patent preparation.
Comply with all company safety regulations and procedures. Ensure compliance of assigned staff.
May be required to perform other related duties as required and/or assigned.
How will you get here?
Education and background:
PhD (preferred) or Masters in Biology, Chemistry, Biochemistry or related discipline, or the equivalent education and experience are required
Minimum 3-5 years at Sr. Manager of R&D level in diagnostics or similar regulated markets.
Prior demonstrated success leading teams of at least 5 people.
Proven track record in developing IVD products, with a focus on molecular assays and systems
Experience in assessing the scientific talent of a team, redesigning roles as needed, and developing and recruiting scientific talent
Demonstrated ability to collaborate with and influence colleagues on cross-functional business teams
Comfortable with experimental design and inferential statistics.
Knowledge, Skills, Abilities
Strategic and analytical skill sets
Knowledge of diagnostic market trends
Persistent and flexible in response to change
Reliant Immune Diagnostics is developing innovative medical applications that will disrupt the healthcare industry. You can read more about the company at reliantid.com.
Role: Senior Scientific Manager, R&D - IVD
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