Scientific Director, Clinical Scientist, Oncology Early Development Lead

2 days ago


South San Francisco, California, United States AbbVie Full time
Job Description

AbbVie is seeking a highly skilled Scientific Director, Clinical Scientist to lead the design, conduct, analysis, and reporting of clinical trials in oncology early development. This role will apply scientific training and clinical research experience to support all aspects of drug development, from pre-clinical discovery to clinical proof of concept and commercialization.

Key Responsibilities:
  • Lead the review, interpretation, and communication of scientific data pertaining to the efficacy and safety of compounds in development.
  • Develop program strategy, including clinical development plans, product lifecycle plans, target product profiles, and draft labels.
  • Provide focused scientific and clinical study support from start-up to clinical study report.
  • Participate in scientific education of internal and external stakeholders on pre-clinical and clinical data relevant to the program.
  • Formulate the Clinical Study Brief in collaboration with Discovery, clinical, and cross-functional colleagues.
  • Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
  • Collaborate cross-functionally to create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage assets.
Qualifications:
  • Bachelor's Degree in Science related field with 16 years of related work; Master's Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
  • Strong track record of collaboration in a cross-functional setting.
  • Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
  • Knowledge of clinical trial methodology, regulatory, and compliance requirements governing clinical trials and experience in the design of study protocols.
  • Ability to interact externally and internally to support global scientific and business strategy.
  • Must possess excellent oral and written English communication skills.


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