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Clinical Development Medical Director

Exelixis

This is a Contract position in Alameda, CA posted June 12, 2020.

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 drug 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: • May supervise employees, both directly and indirectly through a dotted line structure or via other subordinate supervisors. EDUCATION/EXPERIENCE/SKILLS: Education: • MD • Board certification or eligibility in Oncology, Hematology/Oncology or specialties or related specialty (e.g. radiation oncology, surgical oncology) is preferred. Experience: • Three to five years of drug development experience in biotechnology or pharmaceutical industry (preferably at least in part with industry sponsor companies) with medical monitoring experience from the Sponsor perspective, or some combination of academia, practice and in oncology studies industry. Note: Individuals with extensive oncology and/or 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, preferably with molecularly targeted or immunological therapies. • Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics). Knowledge/Skills/Abilities: • 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 leaders in relevant therapeutic areas.. • Strong interpersonal, influencing, presentation, written, and verbal communication skills. • Strong organizational and time management skills. • Willingness and ability to be hands-on, learn new skills, collaborate and mentor others. • Ability to travel globally (<20%). 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 partners. 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.
In collaboration with the Exelixis’ clinical teams, the role primarily leads and executes early/late stage clinical trials for oncology products. This individual participates in the design/planning of clinical studies and executes the study plan and interprets study results in collaboration with colleagues. Duties also include 1) establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and final reports; 2) recruiting clinical investigators for clinical research studies; 3) monitoring subject safety in clinical studies and 4) monitoring adherence to protocols and assisting with data review as needed.