Associate Director, Orthopedic Clinical Research

Regulatory Jobs

Warsaw (IN)

On-site

USD 140,000 - 242,000

Full time

29 hours ago
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Benefits offered by this job

Comprehensive benefits
Paid time off

Job summary

Johnson & Johnson’s DePuy Synthes unit is recruiting an Associate Director, Clinical Research in Warsaw IN, with alternative locations in PA, MA, or FL. You will lead global evidence-generation for Knee Reconstruction, partnering with cross-functional teams to deliver high-quality outcomes and support regulatory and market access needs.

You will bring 8+ years in clinical research, strong leadership, and expertise in medical devices and orthopedics, driving studies across phases and ensuring GCP

Qualifications

  • Minimum of 8 years of progressive clinical research or operations experience.
  • At least 2 years of people management experience.
  • Experience managing medical device clinical studies across multiple phases.
  • Knowledge of Good Clinical Practice (GCP) and regulatory standards.
  • Experience with global regulatory submissions and post-market research preferred.

Responsibilities

  • Lead a team of clinical research professionals to deliver global evidence-generation strategies for the Knee Reconstruction platform.
  • Partner with Clinical Operations, Biostatistics and Data Management to deliver programs on time, within budget, and in compliance with applicable regulations and internal procedures.
  • Collaborate with regional clinical leaders and Global Strategic Marketing, Medical Affairs, Regulatory Affairs, and other stakeholders to identify evidence gaps and align priorities.
  • Lead clinical research scientists in designing studies to address prioritized gaps and development needs; coordinate feasibility and site start-up.
  • Oversee the dissemination of clinical evidence through reports, abstracts, and manuscripts; support market access and reimbursement.

Skills

Clinical research leadership
People management
Good Clinical Practice (GCP)
Regulatory knowledge
Medical device experience
Orthopedics / joint replacement

Education

Bachelor's degree in Life Sciences, Health Sciences, Engineering
Master's or PhD (preferred)

Job description

Johnson & Johnson’s DePuy Synthes unit is recruiting an Associate Director, Clinical Research in Warsaw IN, with alternative locations in PA, MA, or FL. You will lead global evidence-generation for Knee Reconstruction, partnering with cross-functional teams to deliver high-quality outcomes and support regulatory and market access needs.

You will bring 8+ years in clinical research, strong leadership, and expertise in medical devices and orthopedics, driving studies across phases and ensuring GCP

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