Clinical Development Scientist - Oncology

Location
Foster City, CA
Posted
Apr 27, 2022
Ref
2989891
Required Education
Bachelors Degree
Position Type
Full time

EXAMPLE RESPONSIBILITIES:
  • Acquires and uses knowledge of clinical trial design to develop specific study concept sheets and protocols.
  • Participates in protocol review discussions concerning scientific and procedural aspects of study design.
  • Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with guidance and supervision.
  • With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
  • With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
  • With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
  • Assists in the preparation/review of regulatory documents.
  • Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
  • May be asked to coordinate teams and provide direction.
  • May provide clinical monitoring for one or more clinical studies or components of larger studies.
  • Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.


REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience
  • Typically requires a PharmD or PhD in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
  • MS with 6+ years' relevant scientific and/or drug development experience.
  • BS or RN with 8+ years' relevant scientific and/or drug development experience.
  • Relevant experience in Oncology therapeutic area is preferred.
  • Experienced with Microsoft Office and other job-related programs.

Knowledge & Other Requirements
  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  • Proven analytical abilities as demonstrated through past experience and/or academic research.
  • Understands drug development phases and the nature of associated clinical trials across phases.
  • Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
  • Strong communication and organizational skills.
  • When needed, ability to travel.

For jobs in the United States:

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