Associate Director, Clinical Research
$137,000–$235,750 year
On-siteIrvine, California, United States
Job Summary
Lead a team of clinical research professionals to manage clinical trials and deliver evidence generation and dissemination strategies for multiple complex projects within the Neurovascular Clinical R&D Department. Execute clinical R&D activities in accordance with federal, state, and local laws and Johnson & Johnson procedures, while fostering strong relationships with key opinion leaders, investigators, IRBs, regulatory agencies, and cross-functional partners. Lead study design to develop appropriate clinical trials meeting clinical evidence needs, coordinate input from regional leads on Global Evidence Generation Strategies, and serve as the clinical representative on New Product Development teams. Monitor project budgets to ensure adherence to business plans, lead clinical scientific discussions with regulatory agencies to drive strategy, and develop Post-Market Clinical Follow-up Plans. Manage and mentor resources to provide quality deliverables, provide performance feedback to direct reports, and ensure compliance with Health, Safety, and Environmental practices.
Required Qualifications
- Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science
- A minimum of 8 years related scientific/ technical experience
- Leadership/ management role within Clinical Research
- Significant previous experience in clinical project leadership across multiple studies/ programs
- Experience working well with cross-functional teams
- Experience with budget planning, tracking and control
- Deep expertise in clinical research science and processes
- Broad and extensive understanding of product development processes
- Understanding of team dynamics
- Understanding of related healthcare market environment
- Understanding of clinical trends
- Understanding of global clinical trial regulations
- Ability to lead cross-functional teams to provide scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects
- Proven track record in delivering clinical programs within clinical/ surgical research setting
- On time, within budget and in compliance to SOPs and regulations
- Strong presentation and technical writing skills
- Strong written and oral English communication skills
- Comprehensive understanding of clinical trial regulations across multiple regions
- Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes
- Ability to meet business objectives
- Ability to lead teams to deliver critical milestones, including complex projects
- Advanced technical writing skills
- Strong project management skills with ability to handle multiple projects
- Strong people management skills
- Effective management of project budget processes
- Ability to influence, shape and lead without direct reporting authority
- Strong leadership required in alignment with J&J Leadership Imperatives
- Ability to foster strong partnership with key internal and external stakeholders
- Ability to build strong working relationships with external stakeholders
- Ability to positively influence and shape the way clinical trial management is conducted
- Ability to utilize resources efficiently
- Ability to provide inputs in the development of scientific clinical research strategies for complex programs
- Ability to ensure appropriate escalation of compliance issues
- Ability to ensure clinical programs are delivered on time, within budget and in compliance to SOPs and regulations
- Ability to ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned
Desired Qualifications
- Relevant industry certifications (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR)
- Clinical/medical background
- A minimum of 1-2 year people management related experience
- Medical device experience
- Clinical Evaluations
- Corrective and Preventive Action (CAPA)
- Drug Discovery Development
- Entrepreneurship
- Leadership
- Medicines and Device Development and Regulation
- Presentation Design
- Regulatory Affairs Management
- Relationship Building
- Research Documents
- Safety-Oriented
- Scientific Research
- Strategic Change
- Study Management
- Tactical Planning
- Technical Credibility
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