Associate Director, Clinical Research
On-siteHong Kong, Hong Kong
Job Summary
Lead a team of clinical research professionals to manage clinical trials and deliver evidence generation and dissemination strategies for complex Neurovascular projects. Execute Clinical R&D activities while leading study design to meet clinical evidence needs and fostering alignment with Global Strategic Marketing, Medical Affairs, and Regulatory Affairs. Coordinate input from regional leads to develop strategies supporting new product development and life-cycle management. Monitor assigned project budgets to ensure adherence to business plans and lead clinical scientific discussions with regulatory agencies to drive strategy support. Deliver clinical programs on time, within budget, and in compliance with regulations and SOPs by managing resources and providing performance feedback to direct reports. Travel approximately 20-25% depending on program phase.
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, including 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 along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and 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, including complex and/ or transformational 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 and to meet business objectives
- Through transparent leadership, support shaping a high-performing team with a global culture
- 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
- Change agent in team development and progression
- Strong leadership required in alignment with J&J Leadership Imperatives: Connect – Foster strong partnership with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS
- Shape – Build strong working relationships with external stakeholders and through efficient use of resources, positively influence and shape the way clinical trial management is conducted and resources are utilized
- Lead – Continue to develop expertise to be able to provide inputs in the development of scientific clinical research strategies for complex programs, in line with global strategies
- Through transparent leadership, ensure appropriate escalation of compliance issues
- Deliver - Ensure clinical programs are delivered on time, within budget and in compliance to SOPs and regulations
- Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned
- Ability to travel approximately 20-25% depending on the phase of the program
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
- 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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