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: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 & RESPONSIBILITIESIn 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.
Required Skills:Preferred Skills: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
