Clinical Science Director

2 weeks ago

Alameda CA United States Exelixis Full time

SUMMARY/JOB PURPOSE:

In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. 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.

Essential Duties And Responsibilities:

  • In collaboration with the clinical study teams for a specific product candidate in clinical development, designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
  • Interacts with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols.
  • Researches and assists in the selection of investigators for clinical studies.
  • 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.
  • May act as contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.
  • 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.
  • Contributes to the writing and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
  • Provides feedback on emerging clinical and competitive trends.
  • Coordinates and facilitates clinical oncology studies 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.

Supervisory Responsibilities:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

  • Pharm.D., PhD, or M.D. and a minimum of 8 years of related experience; or,
  • Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

  • 5-8 years of clinical development experience in the biotechnology or pharmaceutical industry or the equivalent combination of academia and industry.
  • Participated in clinical oncology studies with molecular targeted or immunological therapies.

Knowledge/Skills:

  • Comprehensive and detailed knowledge of clinical trial implementation and drug development process.
  • Experience in the design, execution, and reporting of 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.
  • May lead or manage 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.

Working Conditions:

10-25% travel requirement.

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