Johnson & Johnson - Horsham, PA

posted 3 months ago

Full-time - Director
Remote - Horsham, PA
Chemical Manufacturing

About the position

Johnson & Johnson Innovative Medicine is seeking a Director, Clinical Research Scientist to join our Medical Affairs Lung Therapeutic Area Strategy Team in Horsham, PA. This role offers the opportunity to work on groundbreaking projects that contribute to the development of life-changing medical breakthroughs. As a Clinical Research Scientist, you will be integral to the US Medical Affairs Solid Tumor group, participating in and potentially leading various aspects of Phase I-IV clinical research trials. You will collaborate closely with the Therapeutic Area Head, Medical Directors, and other functional areas within Johnson & Johnson to facilitate research for our oncology products. In this position, you will serve as the Study Responsible Scientist (SRS) for Medical Affairs-led interventional clinical trials, overseeing investigator-initiated and collaborative studies. You will support the Study Responsible Physician (SRP) in medical, safety, and scientific oversight activities. Your key responsibilities will include being the primary contact for clinical study activities, reviewing and assessing new clinical study proposals, and leading the development of company-sponsored studies from protocol development through to study close-out and publication. You will also monitor and analyze clinical trial data, assist with safety reporting, and develop abstracts and publications for company-sponsored studies. Additionally, you will establish relationships with external investigators and thought leaders, support the execution of advisory boards, and collaborate with various stakeholders on strategic project execution. This role requires excellent communication skills, the ability to work in a cross-functional team environment, and a willingness to adapt to changing circumstances. You will also be expected to travel up to 25% as part of your responsibilities.

Responsibilities

  • Serve as the key point person for the status of clinical study activities
  • Review and assess new clinical study proposals
  • Lead company-sponsored study development from protocol development to study close-out
  • Monitor, review, and analyze clinical trial data
  • Assist with investigation and acquisition of additional necessary data for safety reporting
  • Develop abstracts and scholarly publications for company-sponsored studies
  • Establish relationships and communicate with external investigators and thought leaders
  • Support the development and execution of advisory boards
  • Collaborate with the TAH, Medical Directors, RWE Team, and other stakeholders on project execution
  • Participate in the review of promotional materials
  • Lead trainings for internal and external stakeholders
  • Support other initiatives and projects within the TA as needed

Requirements

  • Advanced degree required; PharmD, PhD, MD/DO preferred
  • A minimum of 8 years of progressively responsible experience in clinical research and development or related experience within the industry
  • Experience in oncology therapeutic area is required; experience in lung cancer preferred
  • Significant experience with clinical trials including protocol development, case report forms, informed consent, study initiation, and clinical data monitoring
  • Excellent written and oral communication skills
  • Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint) preferred
  • Demonstrated ability to work and lead in a cross-functional team environment
  • Flexibility and adaptability to changing circumstances
  • Ability to travel up to 25% required

Nice-to-haves

  • Experience with Real World Evidence (RWE)
  • Familiarity with regulatory requirements for clinical trials
  • Experience in developing training materials for clinical study teams

Benefits

  • Competitive salary
  • Comprehensive health insurance
  • 401(k) retirement plan
  • Paid time off and holidays
  • Tuition reimbursement
  • Employee wellness programs
  • Diversity and inclusion initiatives
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