Job Information
System One Executive Medical Director Clinical Development in King of Prussia, Pennsylvania
Title: Executive Medical Director, Clinical Development – Late Phase
Location: Remote 100%
Type: Perm
Start Date: ASAP
Leading Pharmaceutical Company located in PA/NJ is hiring a Executive Medical Director, Clinical Development – Late Phase 5+ years industry experience. If you want to be a part of this groundbreaking work, please apply!
SUMMARY/JOB PURPOSE:
In collaboration with the clinical teams, the primary role is to lead and execute late-stage clinical trials for solid tumor oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion.
Essential Duties And Responsibilities:
• Support the establishment of clinical trial strategies for oncology products in development.
• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Act as medical monitor for company sponsored trials.
• Support project teams with therapeutic area specific information.
• Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
• Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease specific area.
• Ensure consistency of scientific and development strategies for oncology products in development.
• Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.
Education/Experience:
• MD with board certification or eligibility in Oncology or Hematology/Oncology and 10 years post-residency related experience; or,
• Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
• Nine years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered.
• Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
• Participated in clinical oncology studies with molecular targeted or immunological therapies.
• Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.