Associate Director, Clinical Research

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com. As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: Discovery & reputed company-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology reputed company Job Posting Locations: Hong reputed company, Hong reputed company Job reputed company: reputed company, Neurovascular, is reputed company an Associate Director, Clinical Research, to join reputed company. At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company and profoundly reputed company 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 reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that reputed company with your preferred location(s): US - Requisition Number: R-081415 reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the reputed company of Neurovascular? reputed company to join reputed company 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 reputed company to wellness. Learn more at https://www.jnj.com/medtech.  reputed company Associate Director, Clinical Research will be leading reputed company of clinical research professionals to manage reputed company and to deliver evidence reputed company/dissemination strategies (EGS/ EDS) for multiple and/or reputed company reputed company reputed company the JJMT Neurovascular Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization. DUTIES & RESPONSIBILITIES* In accordance with reputed company applicable federal, state and local laws/regulations and Corporate reputed company, procedures and guidelines, this position: Is responsible for the execution of Clinical R&D activities for multiple and/ or reputed company reputed company. Manages team of clinical research professionals to manage reputed company; Is responsible for clinical team’s reputed company and collaboration with key opinion leaders, investigators, IRBs/reputed company, Regulatory agencies, contractors/vendors, societies, associations, and company personnel; Provides inputs on the development and executes the delivery of appropriate Global Evidence reputed company Strategies (EGS)/ Evidence Dissemination Strategies (EDS) to support New Product Development and Life-Cycle Management for transformational/ reputed company programs, Foster reputed company relationships with reputed company relevant Clinical reputed company and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market reputed company, R&D, etc), ensuring cross-functional alignment; Coordinates input and alignment from key regional MD Clinical R&D leads and other countries/ reputed company in the development of the EGS/ EDS; Leads study design to reputed company appropriate reputed company to meet the clinical evidence needs; Fosters strong working relationships with reputed company stakeholders; Partners with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market reputed company and reimbursement; Is responsible for delivery of assigned clinical programs, through effective partnership with internal/reputed company stakeholders, to reputed company optimized engagement leading to delivery of clinical project commitments (deliver on time, reputed company 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/ reputed company bodies to reputed company support of the clinical and regulatory reputed company, 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 reputed company reputed company deliverables while maintaining reputed company efficiency; Is responsible for providing performance feedback to reputed company reports (if applicable) as reputed company as coaching and assistance in their development; Responsible for communicating business reputed company issues or opportunities to next management level; Responsible for following reputed company Company guidelines reputed company to Health, Safety and Environmental practices as applicable; For those who supervise or manage a staff, responsible for ensuring that subordinates follow reputed company Company guidelines reputed company to Health, Safety and Environmental practices and that reputed company resources needed to do so are available and in good condition, if applicable; Responsible for ensuring personal and Company compliance with reputed company 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 reputed company scientific/ technical experience, including leadership/ management role reputed company Clinical Research. Significant previous experience in clinical project leadership across multiple studies/ programs is required. Experience working reputed company 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 reputed company 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, reputed company reputed company market environment, clinical trends, and global clinical trial regulations; Ability to reputed company cross-functional teams to reputed company scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) reputed company, including reputed company and/ or transformational reputed company; Proven reputed company record in delivering clinical programs reputed company clinical/ surgical research setting, on time, reputed company 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 reputed company; Ability to collaborate across different functional areas reputed company 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; Demonstrates competencies in the following area are required: Ability to reputed company teams to deliver critical milestones, including reputed company reputed company Advanced technical writing skills Strong project management skills with ability to handle multiple reputed company Strong people management skills Effective management of project budget processes Ability to influence, shape and reputed company without reputed company reporting authority Change agent in team development and progression Leadership Competencies: Strong leadership required in alignment with J&J Leadership Imperatives: reputed company – Foster strong partnership with key reputed company stakeholders to ensure development and reputed company delivery of innovative EGS/ EDS. Shape – Build strong working relationships with reputed company stakeholders and through efficient use of resources, positively influence and shape the way clinical trial management is conducted and resources are utilized. reputed company – Continue to reputed company expertise to be reputed company to reputed company inputs in the development of scientific clinical research strategies for reputed company programs, in line with global strategies. Through transparent leadership, ensure appropriate escalation of compliance issues. Deliver - Ensure clinical programs are delivered on time, reputed company budget and in compliance to SOPs and regulations. Ensure reputed company sponsored studies have appropriately trained clinical trial leaders/ specialists assigned. LOCATION & TRAVEL REQUIREMENTS Primary location for this position is per management discretion.  The position may be performed remotely. Ability to travel approximately 20-25% depending on the phase of the program reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company.  reputed company is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, reputed company applicants please contact us reputed company https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.     Required Skills:     Preferred Skills: Clinical Evaluations, Corrective and Preventive reputed company (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical reputed company (GCP), 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 Apply To This Job