Associate Clinical Science Director

About the role

This position collaborates with clinical and project teams of the company to design, plan, and develop clinical evaluation research studies in oncology with a focus on solid tumors. This role 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.

Responsibilities

• Collaborates with the clinical teams for a specific product candidate to design, prepare and initiate 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 monitors to enable interactions 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 presentations 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 monitors.
• 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.

Requirements

Must have experience with clinical studies in oncology. This position is located at Exelixis headquarters in Alameda, CA.

Qualifications

• Pharm.D., PhD, or M.D. or equivalent education
• A minimum of five years of related experience
• 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

Skills

• 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

Benefits

The base pay range for this position is $172,000 - $244,000 annually. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.