What are the responsibilities and job description for the FDA PRODUCT DEVELOPER position at Hoskinson Biotechnology?
About:
Hoskinson Health & Wellness Clinic is a leading-edge healthcare institution with a strong commitment to innovation in anti-aging and regenerative medicine. We are rapidly expanding our research and development capabilities, with a focus on creating FDA-approved products that address emerging trends in healthcare. Stem cell research is a cornerstone of our efforts, and we aim to bring cutting-edge, commercially viable solutions to market that redefine patient care and outcomes.
In addition to clinical care, we are deeply engaged in clinical research, with a dedicated team focused on understanding the 12 causes of aging. Their discoveries help us to shape healthcare solutions that could maintain and improve your health as you age. We are in the process of building a state-of-the-art research lab aimed at developing FDA-approved products and advancing evidence-based medicine.
Job Summary:
We are seeking an FDA Product Developer with extensive experience in product development, particularly in stem cell research and regenerative medicine. This role is pivotal in bridging the gap between science and commercialization, ensuring the success of groundbreaking products in the healthcare market.
Key Responsibilities:
Product Development Leadership
- Drive the end-to-end development of medical products, with a focus on stem cell therapies, from concept to FDA approval and commercialization.
- Collaborate with the science division to focus their efforts, streamline project timelines, and ensure steady progress.
- Interface with operations and leadership to align product development with organizational goals and market demands.
- Bring forward innovative, cutting-edge product ideas and provide detailed feasibility analyses, including cost, time, and resource requirements.
Regulatory Expertise
- Navigate the FDA approval process, ensuring compliance with all regulatory requirements.
- Provide strategic guidance on the design and implementation of FDA trials, including timelines, resource allocation, and patient recruitment.
- Establish and maintain relationships with external clinical sites to support trials as they progress to larger patient cohorts.
- Offer insights into trial complexity, including statistical requirements and necessary resources to achieve FDA approval.
Stem Cell Product Development
- Leverage proven experience with stem cell therapies or related FDA-approved products to lead development initiatives.
- Translate scientific advancements in stem cells into viable commercial products that align with the organization’s vision for anti-aging and regenerative medicine.
- Act as the go-to expert on stem cell research, providing insights into emerging trends and opportunities in the field.
Market and Commercial Strategy
- Conduct market analyses to assess sales potential, ROI, and economic impact of proposed products.
- Develop comprehensive product plans, including pricing, launch strategies, and market positioning.
- Partner with marketing and sales teams to ensure successful product launches and sustained market adoption.
Team Collaboration and Innovation
- Interface with the science team to transform abstract ideas into focused, actionable projects.
- Encourage creativity and forward-thinking while maintaining a pragmatic approach to development timelines and budgets.
- Serve as a liaison between research and operations to align scientific goals with organizational priorities.
Qualifications:
- Advanced degree in a relevant field (e.g., biomedical engineering, pharmacology, or life sciences). MBA preferred.
- Minimum 10 years of experience in product development within the healthcare industry, including a proven track record of launching FDA-approved products.
- Specific expertise in stem cell research and development, with a history of successfully navigating FDA processes for stem cell-based products.
- Strong understanding of anti-aging and regenerative medicine trends.
- Exceptional leadership skills with a demonstrated ability to manage multidisciplinary teams and keep complex projects on track.
- Financial acumen, including experience with cost analysis, ROI projections, and budgeting.
- Proven ability to collaborate with external clinical sites for patient recruitment and trial management.
- Outstanding communication and problem-solving skills, with the ability to present complex concepts to diverse stakeholders.
Why Join Us?
- Work in a pioneering organization that combines cutting-edge science with a commitment to redefining patient care.
- Be at the forefront of stem cell research and regenerative medicine, bringing transformative products to market.
- Collaborate with a multidisciplinary team of innovators in a supportive, family-owned environment.
- Enjoy access to state-of-the-art facilities and the opportunity to make a significant impact in a rapidly growing institution.
Benefits:
- Health Insurance: The company covers 100% of health insurance premiums, including medical, dental, vision, short term disability, long term disability, and Life Insurance coverage.
- Supplemental Insurance: Employees have voluntary access to additional policies such as hospital, cancer coverage, accident insurance, and voluntary life through a supplemental provider.
- Retirement Benefits: Enjoy a generous retirement plan with a competitive company match - no waiting period required.
- Paid Time Off (PTO): Benefit from a generous PTO policy.
- Professional Development: Hoskinson Health and Wellness Clinic supports the professional growth of all employees by offering assistance for continuing or additional education with Human Resources approval.
Company Mission and Philosophy:
Hoskinson Health & Wellness Clinic is owned by physicians who have teamed together to help end discrepancies they have seen for decades in the healthcare space. Our mission is to help patients truly live better, healthier lives by providing comprehensive care through a variety of specialists and support services. To ensure this mission is met, we focus on integrating highly effective technology, encourage collaboration among the team, and take lower patient volumes to allow patients more time with our staff.
This is a unique opportunity to shape the future of regenerative medicine and anti-aging therapies. If you have the expertise and drive to lead transformative innovation, we want to hear from you!
Hoskinson Health & Wellness Clinic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. The Clinic is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, contact Human Resources at 307-387-9850.