In collaboration with the Exelixis clinical teams, the Medical Director leads and executes early and/or late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps interpret 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 event 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 (including but not limited to assessment of eligibility and safety events requiring study drug dose modification; data review; protocol writing; presentation at investigator meetings, steering committee meetings, DMC reviews; contribution to clinical study reports; publication review).
Support project teams with therapeutic area-specific information.
Collaborate with internal safety group in analyzing and reporting 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:
Manages a team on a regular basis.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
MD (board certification or eligibility in Oncology or Hematology/Oncology) and a minimum of 5 years post-residency related experience; or
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Five years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic clinical experience but without experience in the pharmaceutical industry may be considered
Hands-on experience in the design, execution, medical monitoring, and reporting of controlled clinical trials in oncology.
Participation 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:
Works effectively in a cross-functional/matrix environment
Has broad expertise or unique knowledge and skills supporting contribution to development of company objectives and principles and effective achievement of goals
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Develops and maintain relationships with significant key opinion leaders.
Communicates with strong interpersonal, influencing, and presentation (both written and verbal) skills
Has strong organizational and time management skills
JOB COMPLEXITY:
Works on complex problems where analysis of situations or data requires 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.
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DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
