In collaboration with clinical and project teams of the company, the Associate Clinical Science Director designs, plans and develops clinical evaluation research studies in oncology with focus on solid tumors. This position may assist in or prepare and author 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:
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.
Works with medical monitor to enable interaction with clinical sites and thought leaders in oncology to assist sites in efficient completion of clinical trials
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 in coordination with medical monitor.
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.
Delivers high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.
Maintains clinical and technical expertise in the therapeutic area of Oncology
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
Pharm.D., PhD, or M.D. or equivalent education and a minimum of five years of related experience.
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Three to Five years of clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
Participated in clinical oncology studies with molecular targeted or immunological therapies.
Knowledge/Skills:
Detailed knowledge of clinical trial implementation and drug development process.
General knowledge of other related disciplines in the execution of clinical trials.
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.
WORKING CONDITIONS:
10-25% travel requirement.
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
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.
