SUMMARY/JOB PURPOSE:
In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early/late stage clinical trials for 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. Monitors adherence to protocols and determines study completion.
Essential Duties And Responsibilities:
- 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.
Supervisory Responsibilities:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 5 years of post-residency experience.
- Equivalent combination of education and experience
Experience/The Ideal for Successful Entry into Job:
- 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).
Knowledge/Skills:
- Proven ability to effectively work in a cross-functional/matrix environment
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Develops technical and/or business solutions to complex problems.
- Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
- Ability to develop and maintain relationships with significant key opinion leaders.
- Strong interpersonal, influencing, presentation, and written and verbal communication skills
- Strong organizational and time management skills
JOB COMPLEXITY:
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Works on abstract problems across functional areas of the business
- Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
- Regularly interacts with executives and/or major customers.
