Associate Director, Clinical Research

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology All Job Posting Locations: Hong Kong, Hong Kong Job Description: Johnson & Johnson MedTech, Neurovascular, is recruiting an Associate Director, Clinical Research, to join our team. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): US - Requisition Number: R-081415 Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Neurovascular? Ready to join a team that’s reimagining how we heal? Our Neurovascular team develops leading solutions for hemorrhagic and acute ischemic stroke. You will join a proud heritage of continually elevating standards of care for neurovascular stroke patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech. JOB SUMMARY This Associate Director, Clinical Research will be leading a team of clinical research professionals to manage clinical trials and to deliver evidence generation/dissemination strategies (EGS/ EDS) for multiple and/or complex projects within the JJMT Neurovascular Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization. DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Is responsible for the execution of Clinical R&D activities for multiple and/ or complex projects. Manages team of clinical research professionals to manage 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; Provides inputs on the development and executes the delivery of appropriate Global Evidence Generation Strategies (EGS)/ Evidence Dissemination Strategies (EDS) to support New Product Development and Life-Cycle Management for transformational/ complex programs, 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), ensuring cross-functional alignment; Coordinates input and alignment from key regional MD Clinical R&D leads and other countries/ regions in the development of the EGS/ EDS; Leads study design to develop appropriate clinical trials to meet the clinical evidence needs; Fosters strong working relationships with external stakeholders; Partners with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement; Is responsible for delivery of assigned clinical programs, through effective partnership with internal/external stakeholders, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs); Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders; Monitors assigned project budgets to ensure adherence to globally defined 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, in line with global frameworks; Serves as the clinical representative on a New Product Development team; Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports, in line with global frameworks; Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging; 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; Responsible for communicating business related issues or opportunities to next management level; Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable; For those who supervise or manage a staff, responsible for ensuring that 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, if applicable; Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures; Performs other duties assigned as needed; EXPERIENCE AND EDUCATION* Education Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required. Experience 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 is required. Experience working well with cross-functional teams is required. Experience with budget planning, tracking and control is required. Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR,…). Clinical/medical background is a plus. A minimum of 1-2 year people management related experience is a plus. Medical device experience is highly preferred. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* Functional and Technical Competencies: 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 D