What are the responsibilities and job description for the Clinical Development Scientist position at Integrated Resources, Inc ( IRI )?
Job Title: Senior Clinical Development Scientist - Ultrasound Group
Responsibilities:
- Develop, generate, and disseminate clinical and economic evidence ensuring innovation and best-in-class clinical evidence for the Ultrasound business.
- Provide strategic guidance for clinical and economic evidence across the entire end-to-end (E2E) development process, from ideation to post-market for products in the Ultrasound business.
- Collaborate with key internal and external stakeholders to provide expertise and lead clinical initiatives through non-clinical and clinical strategies for new product development and product life cycle management.
- Drive the execution of clinical programs and/or trials, ensuring quality and timeliness to support regulatory requirements, with agility and responsiveness during design, execution, and interpretation of trial data.
- Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations to support claims, reimbursement, health economic outcomes, and/or market access.
- Ensure appropriate preparation, interpretation, and dissemination of evidence, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, and peer-reviewed manuscripts.
- Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations and the review process of clinical evidence for marketing authorization and line extensions.
- Support clinical evidence generation during sponsor regulatory inspections.
Qualifications:
- 7 years of experience in clinical research, development, and real-world evidence (RWE).
- Strong scientific background with experience in Artificial Intelligence algorithm clinical performance validation.
- Expertise in innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks.
- Working knowledge of biostatistics and study design.
- In-depth knowledge of GCP, FDA regulations, EU-MDR regulations, and product development design controls for medical devices.
- Strong writing skills for creating high-quality clinical documents, including final reports, clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports, and scientific publications.
- A medical or scientific education (MD or PhD).
- Ability to think analytically and present statistical methods and results to a variety of audiences, including non-statisticians.
Additional Requirements:
- Self-directed with a strong work ethic, agility, and the ability to work in a purposeful environment.
- Ability to collaborate effectively and influence decision-making with cross-functional teams and external partners.
- Ability to travel up to 15% (domestic and international) as required by business needs.
