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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 currently seeking the best talent for an Associate Director, Clinical Science & External Research (CSER) to support our Electrophysiology team. This role is based in Irvine, CA and will work a Flex/Hybrid schedule with 2-3 days per week in office. Relocation assistance is available to qualified candidates.

Purpose: The Associate Director, Clinical Science & External Research (CSER) will drive end-to-end evidence generation and dissemination strategies (EGS/EDS) of scientific findings from clinical trials and postmarket studies sponsored by Johnson & Johnson MedTech Electrophysiology to generate clinical evidence for the company's pipeline that impacts patient lives. In collaboration with cross-functional teams and study investigators, this leader will support clinical strategy development, craft and execute publication plans, oversee the development of scientific presentations and publications, and supervise the production of materials to educate internal and external stakeholders on the latest clinical evidence. This role will have broad reach and visibility with international team members!

The ideal candidate for this position has proven success in the development of scientific communications and evidence dissemination plans in a medical device or related industry, is versed in supervising personnel writing and editing manuscripts, is knowledgeable of the cardiac arrhythmia medical device industry, and is familiar with pertinent regulations and guidelines governing clinical trial execution and clinical data publication.

You will be responsible for:

• Leads evidence generation and dissemination strategy for strategic portfolio, including developing and implementing publication plans
• Leads publication development in partnership with Clinical Research, Biostatistics and physician authors. Works with Clinical Study Team on data timelines to create long-term forecasting for data availability
• Adhere to external guidelines and Company policies governing the ethical development of clinical data publications while continuing to look at innovation in publication and scientific communications
• Provides critical scientific input to publications, including substantial drafting and editing, as needed
• Develops positive relationships with diverse cross-functional teams including Medical Affairs, Health Economics and Market Access, Global Strategic Marketing, Education, Communications, etc.
• Leads external scientific discussions and builds positive relationships with external physician partners
• Supports congress planning, as needed, including clinical booth activities and scientific sessions coverage
• Supervises and mentors team members and junior CSER staff
• Handles budget associated with assigned research and publication projects
• Leads or participates in monthly literature review with global teams; performs literature review as needed to support EGS and EDS

Qualifications / Requirements:

• Minimum of a Bachelor’s Degree in a Life Science, Physical Science, Nursing, or Biological Science degree. required; PhD/MD/ PharmD strongly preferred.
• 10-12 years of clinical, medical affairs or related technical experience (8-10 with PhD/MD/PharmD) required; industry/academic research experience preferred.
• Minimum of 5+ years of clinical publication planning and clinical writing experience in a medical industry or related setting.
• Proven success managing teams responsible for the day-to-day evidence generation strategy development and execution.
• Able to influence others along with strong written and oral communication skills.
• Advanced project management skills with the ability to prioritize and balance multiple projects ensuring adequate follow through.
• Strategic mentality and critical analytical skill.
• Working knowledge of biostatistical methods.
• Excellent oral, written, and interpersonal communication skills.
• Knowledge of Good Clinical Practices and ICMJE standards.
• This position will be located in Irvine, CA. May require up to 15% travel.
• Medical device experience, especially in cardiovascular and/or electrophysiology therapeutic experience highly preferred.
• Pre- or Post-market study design experience desired.
• ISMPP CMPP™ or AMWA MWC® credentials strongly preferred.

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.

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The anticipated base pay range for this position is:

The anticipated base pay range is $137, 000 to $235, 750.

Additional Description for Pay Transparency:

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 and/or eligible dependents may be 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. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits