Description:
With increasing independence, you will typically lead clinical pharmacology studies of moderate complexity in Inflammation and/or Oncology, which range from first-in human through approval and post-marketing activities. Working in collaboration with others, you are responsible for various aspects of clinical pharmacology program activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study sub-teams, which entails coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution. You will champion model-based drug discovery and development and serve as a clinical pharmacology specialist to cross-functional partners.
EXAMPLE RESPONSIBILITIES:
- As a member of a drug development team, provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
- May author the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area.
- Typically leads and manages design and conduct of clinical pharmacology studies of moderate complexity, which typically includes responsibilities for leading the respective cross-functional study team.
- With input from others, designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans.
- Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design.
- Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies. Addresses clinical issues arising from clinical pharmacology studies.
- Directs the activities and resources for both internal and external study partners.
- Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies.
- Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific presentations or literature.
- Analyzes, interprets and authors documents for clinical and regulatory submissions.
- Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies.
- Presents project updates and other key milestone information to cross-functional partners and stakeholders.
- Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.