Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
In collaboration with clinical and project teams of the company, designs, plans and develops early phase clinical evaluation research studies in oncology with focus on solid tumors. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and publications. Supports project teams with scientific information and provides progress updates related to the assigned clinical studies. Must have experience with clinical studies in oncology.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Interacts with investigators and thought leaders in oncology to facilitate the design of early-stage clinical synopses and protocols.
• Researches and assists in the selection of investigators for clinical studies.
• In collaboration with the clinical teams for a specific product candidate, designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Conducts appropriate literature research for the assigned clinical product candidate.
• Collaborates with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
• Collaborates with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues
• Participates in internal safety meetings, analyzes, and reports potential safety events.
• Collaborates with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
• Helps to write and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
• Proactively provides feedback on emerging clinical and competitive trends.
• Coordinates and facilitates early-stage oncology trials by developing and maintaining excellent working relationships with study investigators.
• Delivers high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.
• Provides clinical education support for internal Exelixis customers.
• Maintains clinical and technical expertise in the therapeutic area of Oncology.
• 10-15% travel requirement.
SUPERVISORY RESPONSIBILITIES:
• May directly or indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.
EDUCATION/EXPERIENCE/SKILLS:
Education:
• PharmD/PhD in a related degree and a minimum of 12 years of related experience; or,
• Equivalent combination of education and experience.
Experience:
• Over 12 years clinical development experience in the biotechnology or pharmaceutical industry or the equivalent combination of academia and industry.
• Participated in early stage clinical oncology studies with molecular targeted or immunological therapies.
Knowledge/Skills/Abilities:
• Comprehensive and detailed knowledge of clinical trial implementation and drug development process.
• Experience in the design, execution, and reporting of early stage clinical trials in oncology with small and large molecule drug candidates.
• Identifies and implements methods and procedures to achieve results with high quality.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Applies strong analytical and business communication skills.
• Highly organized and able to work under tight timelines
• Good public speaking and presentation skills
JOB COMPLEXITY:
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.
• Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.
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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.
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