Sr. Manager, Clinical Pharmacology

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Job Description
 

Sr. Manager, Clinical Pharmacology:

POSITION OVERVIEW:

You will play a supportive role in Oncology clinical pharmacology, which ranges 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. With guidance, you may directly lead design and conduct of clinical pharmacology studies, which will entail coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution.  

EXAMPLE RESPONSIBILITIES:

• With guidance, as a member of a drug development team, may provide input into product development strategies and/or research or clinical development plans for assigned products / projects.
• With guidance, may lead and manage design and conduct of clinical pharmacology studies of moderate complexity, which may include 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 study documentation, data analysis / management plans and scientific presentations or literature.
• Contributes to the preparation of documents for clinical and regulatory submissions.
• May represent 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 moderately complex obstacles within a clinical study and implements solutions.
• 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