J&J Family of Companies
Associate Director, Clinical Science & External Research (Electrophysiology)
J&J Family of Companies, Irvine, California, United States, 92616
Associate Director, Clinical Science & External Research
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. 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. 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: Leadings evidence generation and dissemination strategy for strategic portfolio, including developing and implementing publication plans Leading 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 Adhering 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 Providing critical scientific input to publications, including substantial drafting and editing, as needed Developing positive relationships with diverse cross-functional teams including Medical Affairs, Health Economics and Market Access, Global Strategic Marketing, Education, Communications, etc. Leading external scientific discussions and building positive relationships with external physician partners Supporting congress planning, as needed, including clinical booth activities and scientific sessions coverage Supervising and mentoring team members and junior CSER staff Handling budget associated with assigned research and publication projects Leading or participating 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. The anticipated 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
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. 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. 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: Leadings evidence generation and dissemination strategy for strategic portfolio, including developing and implementing publication plans Leading 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 Adhering 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 Providing critical scientific input to publications, including substantial drafting and editing, as needed Developing positive relationships with diverse cross-functional teams including Medical Affairs, Health Economics and Market Access, Global Strategic Marketing, Education, Communications, etc. Leading external scientific discussions and building positive relationships with external physician partners Supporting congress planning, as needed, including clinical booth activities and scientific sessions coverage Supervising and mentoring team members and junior CSER staff Handling budget associated with assigned research and publication projects Leading or participating 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. The anticipated 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