Clinical Science & External Research Manager
About The Position
Johnson & Johnson MedTech Electrophysiology is recruiting for a Clinical Science & External Research Manager to support the Electrophysiology (EP) business unit based in Irvine, CA. 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. The Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. The Clinical Science & External Research Manager will drive end-to-end evidence generation strategies (EGS). In collaboration with cross-functional teams and research investigators, the CSER manager will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.
Requirements
- A minimum of a Bachelor’s or Master's Degree with at least 8 years of clinical, medical affairs or related technical experience.
- A Life Science, Physical Science, Nursing, or Biological Science degree preferred.
- Medical device experience, especially in cardiovascular and/or electrophysiology therapeutic experience highly preferred
- Pre- or post-market study design and management experience
- Strong project management skills with the ability to balance multiple projects
- 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 and meeting evidence needs.
- Able to influence others along with strong written and oral communication skills
- Strategic mentality and critical analytical skill
- Shown understanding of biostatistical methods
- Successful experience in publication planning and development
- Knowledge of Good Clinical Practices and ICMJE standard
- Leadership in evidence generation strategy
Nice To Haves
- PhD/MD/ PharmD with industry/academic research experience preferred.
- A minimum of 1-2 year people management related experience is desirable for this role.
- Medical writing and systematic literature review desired
Responsibilities
- Handles assigned study programs (investigator Initiated, registries, real-world evidence, collaborative studies)
- Manages the external research program activities including the investigator sponsored trial program ensuring high adherence to SOPs, ICH-GCPs.
- Responsible for new study proposal review, ensures timely decision making and execution of approved studies including while working with external stakeholders
- Utilizes program data and metrics to conduct regular reviews of the program and provides updates to team leadership
- Supports evidence generation and dissemination strategy through external research program, including alignment of publication plan and identifies gaps
- Drives publication development with investigators and internally cross functionally with scientific affairs.
- Provides critical scientific input to publications
- Handles assigned studies (investigator Initiated, registries, real-world evidence or company sponsored post-market /premarket collaborative studies)
- Contributes to protocol development of assigned studies
- Provides input to company and investigator sponsored studies’ protocols as needed
- Develops positive relationship with external researchers and diverse cross-functional teams including Medical Affairs, Biostatistics, clinical research, Compliance, Legal and regulatory to drive timely program execution and success
- Stays on top of current scientific data, leads literature reviews, participates in monthly literature review and shares key insights with global teams
- Oversees budget associated with assigned research projects
- Manages team of study coordinators
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
