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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:

About Cardiovascular

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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for an **Associate Director, Clinical Operations** to support our Electrophysiology business. _This role will work a Flex/Hybrid schedule with 3 days per week onsite in our Irvine, CA office_ . Relocation assistance is available to qualified candidates.

**Purpose** : This Associate Director, Clinical Operations will be leading a team of clinical research professionals to manage clinical trials and to develop evidence generation/dissemination strategies (EGS/ EDS) for multiple and/or complex projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

**You will be responsible for** :

+ Leads a 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.

+ Leads the development and 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.

+ Ensures input and strong alignment from key regional MD Clinical R&D leads and other strategically important 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 relationships with external stakeholders to shape and influence relevant policies, etc.

+ 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).

+ 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.

+ Develop and oversee 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.

+ In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation.

+ 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.

+ Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.

+ 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.

+ 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.

+ Performs other duties assigned as needed.

**Qualifications / Requirements** :

+ Minimum of a Bachelor’s Degree **required** , Advanced Degree _strongly preferred_ . Life Science, Physical Science, Nursing, or Biological Science field desired.

+ At least 8+ years related scientific/ technical experience, including leadership/management role within Clinical Research **required** .

+ Medical device clinical experience is _highly desired_ with a preference for EP and/or Cardiovascular.

+ 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.

+ 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 strategic and 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.

+ Demonstrates competencies in the following area are required:

+ 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

+ Ability to travel approximately 20-25% depending on the phase of the program.

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

\#LI-Hybrid

The anticipated base pay range for this position is :

The base pay range for this position is $137,000 to $235,750.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits