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 **Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Clinical Development & Research – Non-MD **Job Category:** People Leader **All Job Posting Locations:** Irvine, California, United States of America **Job Description:** We are searching for the best talent for an Associate Director of Clinical Research located in Irvine, CA and Santa Rosa, CA. Purpose: 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. Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will: + 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. Education: + Minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, or Biological Science, or related field. Required Skills & Experience: + 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 Preferred Skills & Experience: + Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…) + Clinical/medical background + Medical Device experience Other: + This position will be based in Irvine, CA or Santa Rosa, CA and may require up to 20% travel. The anticipated base pay range for this position is [$137,500] to [$235,000] The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.