Scientific Director Oncology Clinical Development Lead

5 days ago


North Chicago Illinois, United States AbbVie Full time
Job Summary

As a Scientific Director Oncology Clinical Development at AbbVie, you will oversee the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program. You will participate in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Key Responsibilities
  • Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.
  • Oversee project-related education of investigators, study site personnel, and AbbVie study staff.
  • Have overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
  • Along with Clinical Operations, be responsible for oversight of study enrollment and overall timelines for key deliverables.
  • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses, and other program documents.
  • May oversee the work of Associate Scientific Directors and/or Clinical Scientists working on the same or related programs.
  • Provide in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects.
  • May participate in due diligence or other business development activity.
  • As required by program needs, contribute in partnership with Discovery colleagues to design and implementation of translational strategies.
  • May serve on an Integrated Evidence Strategy Team (IEST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
  • Act as a clinical interface and actively solicit opinion leader interactions related to the molecule and disease area; partner with Medical Affairs, Commercial, and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stay abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serve as a clinical representative for key regulatory discussions.
  • Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality standards in conducting research.


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