Head of Clinical Development – Immunotherapy and Biomarkers

Head of Clinical Development – Immunotherapy and Biomarkers

RESPONSIBILITIES

  • Provide clinical leadership and focus for R&D to ensure the creation of comprehensive product development plans from concept to launch
  • Develop actionable plans with anticipate regulatory requirements and timelines to support validation and labeling efforts
  • Provide timely product development requirements to operations which will support scaling infrastructure and capacity to support new product/market needs.
  • Experience writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis and presentation of data to internal and external audiences.
  • Ability to work in a matrix environment with other departments to include Project Management, Regulatory Affairs and Medical Affairs.
  • Excellent oral, written and personal communication skills.
  • Strong clinical research, leadership and management experience
  • Demonstrated experience leading collaborations with RA, QA, R&D, Medical and Commercial to successful product launch.

please email CV to jobs@tseworldwide.com

Author: TSEWORLDWIDE

Michael is a 1996 graduate from Rutgers, The State University of NJ where he majored in Political Science. After Rutgers, Michael spent a year in Israel studying and working with early stage tech companies. After returning to the US, Michael spent 5 years with The Princeton Review in Operations of their graduate level courses. In 2001, Michael joined a staffing company where he led his office in sales of IT consulting services. In 2003, Michael started TSE and quickly found a niche in Strategy Consulting. He has formed partnerships with some of the leading consultancies in the areas of portfolio strategy, commercial assessment, market assess, payer strategy and operational effectiveness. Michael has helped consultancies and client side companies make key hires. In addition to recruiting, Michael helped Rutgers University create their Center for Innovative Ventures of Emerging Technologies and served as an Entrepreneur-in-Residence and Sounding Board Member for 5 years. He continues to stay active in the field of higher learning helping students of the sciences think about careers in the pharmaceutical industry.