Director, Clinical Affairs & Evidence Strategy

Saluda Medical; Northern (KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Saluda Medical is seeking a Director, Clinical Affairs to lead the clinical study program, shape evidence generation strategy, and supervise planning, implementation, and reporting of clinical studies and regulatory activities.

You will partner with R&D, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality and Operations to enable global market access for our closed-loop neuromodulation therapy.

Qualifications

• 10+ years direct clinical and regulatory experience in medical devices.
• Experience developing clinical evidence strategies and conducting clinical trials.
• Ability to synthesize complex clinical data into written format.
• Experience with FDA and regulatory agencies.
• Knowledge of ICH/GCP and FDA medical device regulations.
• Experience with neurostimulation industry preferred.

Responsibilities

• Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity/quality.
• Establish detailed program plans, drive program execution toward objectives, assess risk and implement strategies for successful clinical delivery.
• Contribute to strategic direction for clinical affairs objectives and processes.
• Direct and collaborate with internal and external staff to assure successful conduct of clinical programs.
• Develop protocols, statistical analysis plans, reports and other clinical study documentation.
• Support and contribute to manuscripts, abstracts, data presentations, and health economic value initiatives.
• Promote and embody a high-performance culture.
• Lead issue identification and resolution across programs.

Skills

Clinical regulatory leadership

FDA regulatory experience

ICH/GCP knowledge

Clinical trials design

Neurostimulation knowledge

Data interpretation

Cross-functional collaboration

Education

Bachelor's degree in science/biomedical/health

Master's or PhD preferred

Tools

EDC systems

Clinical trial management tools

Job description

Saluda Medical is seeking a Director, Clinical Affairs to lead the clinical study program, shape evidence generation strategy, and supervise planning, implementation, and reporting of clinical studies and regulatory activities.

You will partner with R&D, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality and Operations to enable global market access for our closed-loop neuromodulation therapy.