We are looking for a highly motivated, independent but collaborative minded R&D Director. The role will lead the provision of ongoing R&D support to a defined RenegadeBio portfolio of products through the management and development of a team of people. Focus will be on the development of novel miRNA based assays as well as other types of molecular diagnostics including but not limited to LCMS, PCR, ELISA, NGS, Flow Cytometry or others. Lead and manage a team under the supervision of the VP of Product Development to provide first line R&D maintenance support to the portfolio of RenegadeBio Lab Developed Tests and IVDs.
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- To lead a team responsible for providing R&D support to the portfolio of RenegadeBio products enabling defense, revenue growth and compliance to the brands principle
- To manage an operation that complies fully with required CLIA, CAP and regulatory requirements.
- To interface with key partners and stakeholders (Supply, compliance, marketing, facilities, IT) on a daily basis.
- To be responsible for the management of all technical matters relating to the projects for which he/she has accountability.
- Work with RB regulatory teams or regulatory consultants and/or agencies to ensure our products comply with national, industry and internal standards. Support all regulatory authority questions and ensure that product licenses are managed in line with the required standards.
- Write and submit grant proposals for new non-dilutive funding opportunities from available funding opportunities such as SBIR, BARDA, White House, DARPA, or others.
- Develop a bioinformatics pipeline to analyze complex sets of biological data generated by multi-omics technologies including deep learning/machine learning to conduct systems-biology studies via integrating multi-omics human as well as environmental data.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Educated to a Doctorate Degree level (Chemistry, pharmacy, chemical engineering or other relevant science)
- Minimum 6 years R&D Healthcare experience with a proven track record of delivery of laboratory developed test and in vitro diagnostic test product development
- Proven track record as a leader in planning, prioritization and implementing projects as well as identifying costs savings and problem solving
- Proven track record in active collaboration with R&D and non-R&D functions
- Experience with recruitment, management and development of people.
- Experience of working in a remote managed environment
- Proven experience in managing molecular diagnostic product development; experience with in vitro diagnostics highly preferred
- Experience with early stages of in vitro diagnostic (IVD) and laboratory diagnostic test (LDT) product development through the discovery of biomarkers, development and assay validation of molecular diagnostics required
- Knowledge of GLP and relevant regulatory requirements for diagnostics including CAP/CLIA and FDA
- Experience within a fluid, high-growth environment is preferred
- Working knowledge and experience with project planning software (e.g. Asana, Project365, Google Suite etc.)
- Strong ability to collaborate cross functionally with multiple departments
- Strong experience in problem solving skills and analytical thinking
- Ability to influence teams in a matrix management environment
- Creative and independent thinker; excellent communication skills; good team worker; ability to multitask and work independently; and ability to find creative solutions to problems are required