Senior Director, External Research & Clinical Science

Johnson & Johnson Innovative Medicine; Irvine (CA); On-site; USD 137,000 - 236,000; Full time

Job summary

Johnson & Johnson MedTech Electrophysiology seeks an Associate Director, CSER to drive end-to-end external research programs, including clinical trials and post-market studies, to generate evidence for the EP pipeline. Based in Irvine, CA, you will craft publication plans and lead manuscript development in collaboration with cross-functional teams and investigators.

You will oversee scientific communications, supervise CSER staff, and manage budgets while ensuring GCP compliance and adherence to

Qualifications

• Bachelor’s or Master’s Degree with 10–12 years of clinical, medical affairs or related technical experience, OR PhD/MD/PharmD with 8–10 years of industry/academic research experience preferred.
• Minimum of 5+ years of clinical research, clinical publication planning and writing experience in a medical industry or related setting
• Leadership in managing teams in clinical research or evidence generation strategy
• Excellent oral, written, and interpersonal communication skills
• Knowledge of Good Clinical Practices and ICMJE standards

Responsibilities

• Leads end to end management of external research projects ensuring compliance to SOPs, GCPs and study timelines
• Acts as a key leader from CSER responsible for clinical trial procedures, sponsor management and point of contact for internal and external meetings
• Leads publication plan development as well as execution 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
• Develops subject matter knowledge and leads external scientific discussions and builds positive relationships with external physician partners
• Supports congress planning and scientific sessions coverage
• Supervises and mentors team members and junior CSER staff
• Handles budget associated with assigned projects

Skills

Leadership

Clinical research

Publication planning

Medical writing

GCP

ICMJE standards

Biostatistics

Cross-functional collaboration

Vendor management

Education

Bachelor’s or Master’s Degree in Life Science/Physical Science/Nursing/Biology

PhD/MD/PharmD with 8–10 years in industry/academic research

Job description

Johnson & Johnson MedTech Electrophysiology seeks an Associate Director, CSER to drive end-to-end external research programs, including clinical trials and post-market studies, to generate evidence for the EP pipeline. Based in Irvine, CA, you will craft publication plans and lead manuscript development in collaboration with cross-functional teams and investigators.

You will oversee scientific communications, supervise CSER staff, and manage budgets while ensuring GCP compliance and adherence to