Sr. Clinical Research Scientist

Job Summary of the Sr. Clinical Research Scientist

The Sr. Clinical Research Scientist will play a critical role in leading and managing clinical research activities, with a focus on advancing peripheral nerve science and its clinical applications. This position requires expertise in clinical trial design, data analysis, and regulatory submissions, ideally within the biotech or medical device industries. The successful candidate will collaborate cross-functionally to drive the development and execution of clinical strategies that support product efficacy, safety, and regulatory compliance.

Requirements of the Sr. Clinical Research Scientist

• Advanced degree (PhD, PharmD, MD) in life sciences, clinical research, biomedical engineering or a related field.
• Minimum 5 years of experience in clinical research in the biotech or medical device industry, including experience in leading clinical trials.
• In-depth knowledge of clinical trial design, regulatory requirements, and GCP.
• Experience with FDA submissions, including INDs, BLAs, PMAs, and/or 510(k)s.
• Strong leadership skills with the ability to work in cross-functional teams.
• Excellent written and verbal communication skills, including the ability to present complex clinical data to both scientific and non-scientific audiences.

Responsibilities of the Sr. Clinical Research Scientist

The specific duties of the Sr. Clinical Research Scientist include but are not limited to:

• Clinical Study Design and Protocol Development:

• Lead the design and development of clinical study protocols, including objectives, endpoints, sample size determination, and statistical analysis plans.
• Collaborate with cross-functional teams (regulatory, R&D, biostatistics, etc.) to align study design with regulatory strategies and product development goals.
• Contribute to the development of clinical strategies to support product claims and marketing.

• Clinical Study Execution:
  • Oversee the execution of clinical studies, ensuring compliance with Good Clinical Practice (GCP), relevant regulations, and company standards.
  • Provide scientific oversight and ensure clinical data integrity and quality throughout the study.
  • Manage relationships with key opinion leaders (KOLs), investigators, and clinical research organizations (CROs).
• Data Analysis and Interpretation:
  • Collaborate with biostatistics and data management teams to ensure accurate data analysis and reporting.
  • Interpret clinical study results and generate clinical study reports, publications, and presentations.
  • Provide scientific input on interim analyses, final analyses, and any safety-related issues that arise during the trial.
• Cross-Functional Collaboration:
  • Work closely with R&D, regulatory affairs, quality, and commercial teams to ensure clinical program alignment with business objectives.
  • Participate in project team meetings and provide clinical updates and scientific insights.
  • Support product development by integrating clinical evidence into product design, development, and labeling.
• Scientific Communication and Publications:
  • Develop and deliver scientific presentations at industry conferences, advisory boards, and internal meetings.
  • Lead the preparation and submission of manuscripts for peer-reviewed journals, contributing to the company’s scientific reputation.
• Compliance and Risk Management:
  • Ensure compliance with all relevant clinical research guidelines, ethical standards, and regulatory requirements.
  • Identify and mitigate risks related to clinical trial conduct, including patient safety, data integrity, and operational challenges.
• Innovation and Continuous Improvement:
  • Stay updated on the latest trends, technologies, and methodologies in clinical research and the therapeutic area of focus.
  • Drive process improvements in clinical operations, study design, and data management practices.

Location

13631 Progress Blvd., Alachua, FL 32615

OR

111 West Oak Ave., Tampa, FL  33602

OR

Remote

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Benefits/Compensation