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The primary role of the Vice President, Early Clinical Development, is to lead and execute early stage clinical trials for oncology products in development in collaboration with the Exelixis clinical teams. This individual participates in the design/planning of clinical studies with novel small and large molecule anticancer candidate drugs and assists with the interpretation of study results. Duties include: 1) establishing and approving scientific methods for design and implementation of clinical protocols (first in human studies through proof of concept), data collection systems and final reports, 2) recruiting clinical investigators for early clinical stage research studies, 3) performing adverse event reporting and safety responsibilities monitoring , 4) overseeing the coordination and development of reporting information for reports submitted to the FDA and 5) monitoring adherence to protocols and determining study completion.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop early clinical trial strategies for oncology products in clinical development.
Design, prepare, and initiate early stage clinical study protocols in partnership with cross-functional teams
Member of the Life Cycle Management and Clinical Trial Review committees.
Contribute to business development activities for early development pipeline
Support project teams with early stage development specific information.
Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
Analyze and interpret early clinical trial data and prepare reports for regulatory agencies and publication.
Interact with key opinion leaders and investigators for early development pipeline.
Ensure consistency of scientific and development strategies for early stage products in development.
Maintain the highest level of scientific, clinical and ethical knowledge in early stage development.
Ensures project plans compliance, complies with federal regulations, GCP and good medical practice.
SUPERVISORY RESPONSIBILITIES:
Hire and supervise employees, both directly and indirectly through a dotted line structure or via other subordinate supervisors.
Oversee performance management and career development for direct reports.
EDUCATION/EXPERIENCE/SKILLS:
Education:
MD or MD PhD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty
Experience:
Ten or more years of pharmaceutical/biotech industry or a combination of academia and industry. Note: Individuals with extensive academic experience in clinical research may be considered.
Expertise in the design, execution, and reporting of early stage clinical trials in oncology with small and large molecule drug candidates.
Excellent scientific knowledge relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
In-depth knowledge of medical aspects of GCP, ICH, FDA, guidelines and regulations.
Knowledge/Skills/Abilities:
Excellent leadership skills and 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.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Develops technical and/or business solutions to complex problems.
Strong interpersonal, influencing, presentation, and written and verbal communication skills
Strong organizational and time management skills.
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.
Ability to travel globally (<30%).
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.
Ensures budgets and schedules meet corporate requirements.
Creates formal networks involving coordination among groups. 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.
