Description
Company Description
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.
Job Description
In collaboration with clinical and project teams of the company, this role provides support for the design, planning and development of clinical evaluation research studies in oncology with a focus on solid tumors. This position also provides support in the preparation and authoring of clinical development related documents including study synopses and protocols. Responsibilities also include summarizing study results for the preparation of documents and publications, supporting project teams with scientific information and providing progress updates related to the assigned clinical studies.
Qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Collaborate with the clinical teams for a specific product candidate including the design, preparation and initiation of study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
- Conduct appropriate literature research for the assigned clinical product candidate.
- Work with the medical monitor to enable interaction with clinical sites and thought leaders in oncology to assist sites in efficient completion of clinical trials.
- Maintain clinical and technical expertise in the therapeutic area of Oncology; review scientific journals, attend scientific and key technical meetings.
- Collaborate 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.
- Assist in the writing and/or review of product specific abstracts, publications, and supports the development of presentations for scientific meetings.
- Proactively provide feedback on emerging clinical and competitive trends.
- Deliver high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.
- 10-25% travel requirement.
Supervisory Responsibilities
Education
EDUCATION/EXPERIENCE/SKILLS:
- Pharm.D., PhD, or M.D. or equivalent education and zero or more years of related experience.
Experience
- Zero to two years of clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
- Experience in public presentation required and education program development preferred.
Knowledge/Skills/Abilities
- General knowledge of clinical trial implementation and drug development process.
- 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 understanding and wide application of technical principles, theories, concepts, and techniques.
- 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.
Additional Information
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.
