Associate Director, Clinical Science & External Research (Neurovascular)

Regulatory Toolkit; Irvine (CA); On-site; USD 137,000 - 236,000; Full time

Job summary

Johnson & Johnson in Irvine, CA seeks a CSER Associate Director to drive end-to-end evidence generation and dissemination for our neurovascular and medical devices portfolio. You will develop and execute publication plans, manage investigator-sponsored studies, and collaborate with Clinical Research, Biostatistics, and physician authors to publish clinically meaningful data.

We require a Master’s degree with 10+ years of clinical/medical affairs or an equivalent combination, or a PhD/MD/PharmD

Qualifications

• Master's degree with 10+ years of clinical, medical affairs or related technical experience.
• PhD/MD/PharmD with 8+ years industry/academic research experience preferred.
• 1–2 years people management experience required for this role.

Responsibilities

• Lead evidence generation and dissemination strategy for assigned product portfolio.
• Lead publication development in partnership with Clinical Research, Biostatistics and physician authors.
• Provide clinical input to publications and disseminate findings.
• Develop and implement training and dissemination plans for scientific materials.
• Handle investigator sponsored studies and retrospective real-world evidence studies.
• Mentor junior CSER staff as needed.

Skills

Scientific capabilities

Influence skills

Project management

Analytical thinking

Biostatistics knowledge

Publication planning

Good Clinical Practice

ICMJE standards

Evidence generation leadership

Education

Master's Degree

PhD/MD/PharmD

Life Science degree preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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:

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.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness.

Neurovascular is part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. Neurovascular offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

The Clinical Science & External Research (CSER) Associate Director will drive end-to-end evidence generation and dissemination strategies (EGS/EDS). In collaboration with cross-functional teams and research investigators, the CSER Associate Director will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.

SECTION 2: DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Leads evidence generation and dissemination strategy for assigned product portfolio, including developing and implementing publication plan
• Leads publication development in partnership with Clinical Research, Biostatistics and physician authors
• Provides critical scientific input to publications
• In partnership with cross-function teams, develops and implements training and dissemination plans for scientific communication materials
• Handles assigned investigator sponsored studies
• Leads retrospective real-world evidence (RWE) studies including developing study protocol and report for assigned studies
• Provides input to company and investigator sponsored studies’ protocols as needed
• Develops positive relationship with diverse cross-functional teams including Medical Affairs, Health Economics and Market Access, Global Strategic Marketing, Biostatistics etc. to drive timely project's execution and success
• Leads or participates in monthly literature review with global teams; performs literature review as needed to support evidence generation and dissemination strategies
• Handles budget associated with assigned research and publication projects
• Supports congress planning as needed including clinical booth activities and scientific sessions coverage
• Mentors junior CSER staff as needed

• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that 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, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

SECTION 3: EXPERIENCE AND EDUCATION

• A minimum of a Master's Degree with at least 10 years of clinical, medical affairs or related technical experience.
• PhD/MD/ PharmD with at least 8 years industry/academic research experience preferred.
• A minimum of 1-2 year people management related experience is required for this role.
• A Life Science, Physical Science, Nursing, or Biological Science degree preferred.
• Medical device experience, especially in neurovascular therapeutic experience highly preferred
• Clinical research experience
• Experience with medical writing and systematic literature review desired

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Strong scientific capabilities and research background, can think creatively to bring forth new insights and innovative ideas to grow external research collaborations leading to impactful publications.
• Able to influence others along with strong written and oral communication skills
• Advanced project management skills with the ability to balance multiple projects
• Strategic mentality and critical analytical skill
• Working knowledge of biostatistical methods
• Successful experience in publication planning and development
• Knowledge of Good Clinical Practices and ICMJE standard
• Leadership in Evidence generation strategy

Other: This role is based in Irvine, CA, however remote candidates (in the US) may be considered.

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,external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

Additional Description for Pay Transparency:

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 Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits