Purpose:
Oversee the direction, planning, execution and interpretation of the Precision Medicine strategy associated with clinical trials or research activities of a clinical program. Participates as well as leads cross-functional teams to generate, deliver, and interpret high-quality clinical biomarker data supporting overall product scientific and business strategy.
Responsibilities:
- Manages design & implementation of the precision medicine strategy in support of the overall Product Development Plan, based on medical & scientific principles, knowledge of compliance & regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues.
- Lead cross-functional precision medicine teams to develop an overall precision medicine strategy that may extend to early translation of biomarker strategy from discovery to the clinic. Lead the development of a rigorous, cross-functionally-aligned, vetted precision medicine strategy in collaboration with matrix team members.
- Has responsibility for oversight of precision medicine strategy, monitoring overall timelines, budgets and interpretation, and communication of accumulating biomarker data to key stakeholders.
- Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial, Clinical Development and other functions in these activities as required, consistent with corporate policies.
- Stays 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. May be asked to contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.