The position provides medical leadership and oversight for pancreatic and colorectal cancer programs, including clinical strategy, protocol development, and regulatory execution. The role involves leading clinical study subteams, monitoring data integrity, and collaborating with cross-functional teams to advance the company's oncology portfolio.
The VP will provide medical leadership and oversight for the lung cancer development program, including strategy, protocol design, and regulatory filings. They will also serve as a clinical lead on studies and mentor a team of medical directors and clinical scientists.
The role involves driving the overarching medical strategy and execution for GI cancers, with a specific focus on pancreas cancer. The individual will lead cross-functional teams in clinical development, evidence generation, and KOL engagement while managing medical affairs activities.
Lead GCP activities and provide strategic oversight for QA operations supporting clinical development programs and regulatory submissions. Manage audit programs, lead regulatory inspections, and ensure compliance across GCP, GLP, GVP, and CDx frameworks.
Lead and oversee biometrics activities across all programs from IND-enabling to registration and launch, managing Biostatistics, Statistical Programming, and Clinical Data Management. Represent the biometrics function on the leadership team and manage interactions with regulatory agencies and health authorities.
