The Clinical Affairs Scientist is responsible for conducting the off-site validation studies and clinical studies required to support regulatory submission of BioFire Defense’s regulated and in vitro diagnostic products. This includes project planning, study design, protocol development, and resource management. In addition, the Senior Clinical Scientist is responsible for ensuring that BioFire Defense has policies and procedures in place to ensure compliance with all relevant regulatory requirements and to ensure that validation and clinical studies are conducted in compliance with these policies. Additional responsibilities may include writing/reviewing protocols and reports to support regulatory submissions, preparing submission documents, integrating with the Quality System, ensuring that BioFire Defense studies comply with internal review committee/ethics review board rules, presenting/publishing study results, writing standard operating procedures (SOPs) and work instruction documents (WIDs) relevant to regulatory issues, supporting post-market surveillance of IVD products, and grant/proposal writing. The performance of these responsibilities may require identifying, contracting, monitoring, and interfacing with sub-contractors.
Collaboration with other scientists and personnel in multiple company departments is required to understand the products and resolve technical issues. Excellent writing skills are integral. Contributions to literature, conferences, funding proposals, and patent applications are expected.
Management of Research Associates is required. Support in drafting and reviewing statements of work and cost proposals is required.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System. Ensure that the conduct of the clinical studies is compliant with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.
- Help manage operation primarily of off-site clinical studies of consented patient specimen testing required for regulatory submissions of BioFire Defense in vitro diagnostic products. May also supervise contrived and archived specimen testing, and help to coordinate the merging of comparator test data.
- Participates in planning and execution of regulatory strategy for obtaining regulatory approval/clearance of BioFire Defense’s in vitro diagnostic products as it relates to clinical studies.
- Identifies and establishes collaborations with appropriate clinical laboratories to perform off-site specimen collection and testing during the studies.
- Visit and supervise visits to study sites for study assessment, initiation/training, monitoring, and closeout.
- Select and train clinical studies staff.
- Assemble all data and write clinical study report at conclusion of study.
- Participate in writing of final regulatory documents (e.g., 510K Pre-Market Submission to US FDA).
- Serves as the company expert concerning all relevant regulatory requirements for conducting clinical studies and develops policies and procedures to ensure compliance. Stays current with evolving or new requirements
- Collaborate with R&D team to design pilot test studies by obtaining clinical specimens, organism isolates, or other materials as needed from external collaborators.
- Supports the development and validation of in vitro diagnostic (IVD) reagent test kits and their associated systems. This may involve supervision of sub-contractors and drafting of related sub-contracts
- Support the development of Design Control and Risk Management activities.
- Oversee the performance of study protocols and data evaluation to ensure that the study is conducted according to the protocol. Oversee data verification activities. Identification of technical issues, accompanied by the proposal and execution of constructive solutions is required.
- Ensure testing and reports are delivered in a timely manner. Delays must be communicated to managers well in advance of due date.
- Maintains broad knowledge of state-of –the –art principles and theories.
- Makes contributions to literature, conferences and grant/proposal/SOW writing and patent applications.
- Advises management about scientific issues and regulatory issues related to research and development projects.
- Collaborates with other scientists and personnel in various company departments to resolve technical issues or develop new products.
- Uses professional concepts and company’s policies and procedures to solve moderate range of difficult problems in imaginative and practical ways.
- Supports DoD contracting requests coordinated through the BioFire Defense Program Management Team; attends regular meetings with contractors.
- Works with Quality Assurance Team on audits, medical device reporting, maintaining the SOPs and WIDS for the Quality System.
- Travel to sub-contractors inside and outside the state may be required.
- Occasional travel to sub-contractors outside the country may be required.
- Occasional travel to BioFire Diagnostics is required.
- Must be available for on-site audits as needed.
Training and Education:
- PhD with at least 2 years of experience in development of scientific experiments (may be satisfied in part with post-doctoral training). Some regulatory and/or clinical experience is preferred.
- Strong written and oral communication skills. Basic statistical techniques and proficiency with Microsoft products. Ability to manage research associates and clinical research associates.
Benefits and Compensation:
- We offer competitive salaries
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment