SUMMARY/JOB PURPOSE:
In collaboration with the Exelixis clinical teams, the Senior 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. 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 (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; contributing to clinical study reports; publication review).
- 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:
- Directly supervise employees
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) and a minimum of 8 years post-residency relevant experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
- Minimum of eight 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.
- Understands 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.
- Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
- Ability to develop and maintain relationships with significant key opinion leaders.
- Communicates with strong interpersonal, influencing, and presentation (both 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.
- May ensure budgets and schedules meet corporate requirements.
- Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers
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.
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