Provide complex administrative support to the President of R&D, CSO, and CMO, including calendar management, travel coordination, and meeting organization. Partner with internal departments to facilitate company culture and support R&D functions across multiple locations.
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 Associate Director supports GMP clinical manufacturing operations by reviewing batch records, analytical data, and quality events to ensure regulatory compliance. They also provide quality oversight for clinical supply chains and manage interactions with contract manufacturers and vendors.
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.
The Director/Sr Director will lead the overarching medical communications strategy, including content development, education, and awareness initiatives across molecules and disease states. They will also manage cross-functional execution of scientific platforms, congress planning, and insight collection initiatives.
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 participate in regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA filings. Provide CMC regulatory support through QC review of submission components and collaborate cross-functionally to ensure compliance with global regulatory requirements.
Provide medical leadership and oversight for late-stage clinical trials and registration-enabling trials in solid tumor indications. Lead the late clinical development function, managing strategy, protocol development, and regulatory filings while collaborating with the CMO.
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.
