Clinical Development Scientist - Oncology

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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