- Serve as a lead and SME on product design transfer and late product development activities for both assay and software components of IVS products.
- Contribute to development of OPs and protocols to support development activities
- Support data analysis of verification and validation data
- Assist in product regulatory submission including developing technical reports, crafting interpretations, communications with the Agency on information request.
- Assist R&D in developing technical manuscripts and scientific posters to support products and related science.
- Collaborate with the R&D team to discuss, design and help analyze science that supports our products
- Contribute to the design of clinical studies for discovery, verification and validation
- Collaborate with business development, medical affairs and commercial for product launch
- B.S. or B.A. required.
- 10+ years of experience in Research and Development for IVD products.
- Demonstrated track record in diagnostic product development and/or design transfer.
- Experience with development of diagnostic software
- Demonstrated track record of interacting with successful IVD development companies and other ecosystem constituents.
- Ability to manage multiple priorities and projects simultaneously.
- Experience with Product Development in the healthcare industry (Dx, Rx, Device, etc.)
- Ability to learn clinical and technical information.
- Excellent written and oral skills
- Ability to engage and collaborate with other departments within the organization.
- Ability to engender customer loyalty and satisfaction.
- No direct supervisory responsibilities
Sr Director of Product Development, Late Clin - Austin, United States - Aspira Labs, Inc.
Description
Job Description
Job DescriptionJob Title: Senior Director of Product Development, Late Clinical Development
Department: R&D
Reports To: VP of Research and Development
Location: Austin, TX
FLSA Status: Exempt
POSITION SUMMARY
The Senior Director of Product Development will be responsible for late-stage product development and design transfer of IVD and other products. This individual will be responsible for ensuring products that have completed early development meet analytical, clinical and regulatory requirements for product launch. This includes developing OPs and protocols to complete for design transfer, handling relationships with 3rd party contract research organizations, product manufacturers and global laboratory channel partners. This role will also function in the department to provide reporting, manuscript development, FDA submission development and other communications to support the product.
ESSENTIAL FUNCTIONS
MINIMUM QUALIFICATIONS
KNOWLEDGE, SKILLS, AND ABILITIES
SUPERVISORY RESPONSIBILITIES