The Director of Clinical Sciences will provide leadership in the areas of clinical laboratory management, study design and assay development. This person will work with Research and Development, Clinical Development, Product Development, Business Development and Regulatory groups to provide input a to successfully integrate and translate product requirements into cohesive, clinically and medically-relevant products. This would include input on clinically related RUO products as well as those IVD products undergoing regulatory submission.
- Provide strategic leadership for the development of assays from research to validated clinical assays.
- Provide strategic leadership for the development of diagnostic products. Primary responsibility will be to successfully integrate and translate product requirements into cohesive and medically-relevant products. This would include clinically relevant RUO products as well as products undergoing regulatory submission.
- Provide strategic and technical leadership for designing and implementing studies for support of medically and clinically relevant products. This would include studies for analytic parameters (sensitivity and specificity) and clinical trials for the development of products.
- Provides specific scientific expertise based on his/her molecular biology, chemistry, biologic, or other scientific training.
- Effectively identify, evaluate and manage external partners and technology in the areas of laboratory services, clinical development, data analytics and software needs.
- Participate in the planning, writing and implementation of laboratory focused clinical trials and collaborative studies.
- Author protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications.
- Coordinates and oversees the full implementation and execution of programs with external and internal collaborators within the accepted timelines, budgets and resources.
- Effective verbal and written communication with internal and external stakeholders including clients and regulators.
- Provide general intelligence on key developments in the diagnostics industry as well as current medical practice.
- Willingness to travel up to 25% of the time.
- Must have experience writing protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications
- Minimum of 5 years' experience in the diagnostic or pharmaceutical industry
- Key contacts in the industry
- Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management
- Demonstrate ability to work within a commercial environment and influence in a cross functional role
- Proven track record in communications including presentations, journal publications and training
- Held accountable timelines associated with starting clinical trials and submitting 510Ks and PMAs
- High energy, self-motivated, approachable and articulate team player
- Demonstrates strong leadership capabilities with the ability to lead a cross-functional team (assay development, laboratory, clinical, software, etc.) through a complex development program
- Significant experience with assay development within an academic group, or biotechnology, pharmaceutical or biopharmaceutical company
- Significant experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company.
- Demonstrated ability to design and develop products and to interpret and evaluate clinical data
- The ability to forge strong internal and external partnerships coupled with excellent presentation, communication and interpersonal skills
- Experience in working as part of a smaller team / company and ability to manage projects and time-lines
- Willing to be a player and a coach. Must author documentation and implement trials while coaching junior team members on process and strategy
- PHD, MD or MD/PhD preferred with relevant experience in Chemistry, Molecular Biology and/or Biological Sciences or equivalent experience.
ArcherDX, the NGS applications company, is developing and commercializing a novel approach to target enrichment chemistry. Next-generation sequencing technology based on Anchored Multiplexed PCR (AMP™) generates a highly enriched library of gene targets of interest for downstream genomic sequencing. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.
Unless otherwise stated, all descriptions above are preferred but not required for our ideal candidate. Consideration will be given for comparable experience. ArcherDX is an Equal Opportunity Employer.
We offer competitive compensation and generous benefits programs. E-mail your résumé in confidence with salary requirements to email@example.com.
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