Associate Director Clinical Research

Johnson & Johnson MedTech, a member of Johnson & Johnson family of companies, is recruiting for an Associate Director Clinical Research. This position can be located in Irvine, CA or Santa Rosa, CA.

The J&J MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

This Associate Director Clinical Research will be leading a team of clinical research professionals to manage clinical trials and to develop evidence generation strategies (EGS) for multiple and/or complex projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

• Is responsible for the delivery of assigned clinical programs through effective partnership with internal/external stakeholders (deliver on time, within budget and in compliance with regulations and SOPs);
• Leads a team of clinical research professionals to manage development and execution of clinical trials;
• Leads study design to develop appropriate clinical trials to meet the clinical evidence needs;
• Fosters strong relationships with external physician to support the development and oversight of clinical trials;
• Is responsible for clinical team's interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel.
• Foster collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), facilitating cross-functional alignment;

• Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Develops and oversees assigned project budgets to ensure adherence to business plans;
• Leads clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
• May serve as the clinical representative on a New Product Development cross-functional team;
• Manages and mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Is responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;
• Performs other duties assigned as needed.

• Minimum of a Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science, or related field
• A minimum of 8 years related scientific/technical experience in an industry/sponsor role
• A minimum of 2 years of people leadership/management role within Clinical Research

• Success in fostering strong relationships with external advisors (e.g. HCPs), including collaborating on study design, scientific data interpretation, and strategic input.
• Experience working well with cross-functional teams
• Proficient in budget planning, forecasting, tracking and control

• Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,...)
• Clinical/medical background
• Medical Device experience