Clinical Development Scientist - Oncology
- 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.
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.
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