The Director of Biostatistics will provide strategic guidance on clinical trial design and oversee the execution, interpretation, and regulatory submission of clinical projects. They will also lead cross-functional initiatives and ensure high-quality statistical deliverables in collaboration with internal teams and external CROs.
The Clinical Trial Manager will oversee day-to-day clinical trial operations, including vendor management, study site activities, and cross-functional team leadership. They are responsible for ensuring trials are delivered on time, within budget, and in compliance with GCP/ICH regulatory requirements.
The role involves defining and executing end-to-end bioanalytical strategies for small molecules and biologics across nonclinical and clinical development programs. The incumbent will oversee assay development, validation, and sample analysis at CROs while partnering cross-functionally to support regulatory submissions and project milestones.
The Senior Drug Safety Specialist will lead pharmacovigilance operations for assigned clinical trials, including processing serious adverse events and ensuring regulatory compliance. They will collaborate with cross-functional teams and external vendors to manage safety data, perform quality reviews, and support regulatory reporting requirements.
The Senior Director will define and drive clinical pharmacology and model-informed drug development strategies across the company's oncology portfolio. They will lead clinical pharmacology studies, oversee quantitative analyses, and manage regulatory interactions to support global drug development submissions.
The Executive Director will lead the cross-functional asset strategy team and oversee the end-to-end development of the Next Generation Menin Program. This role involves driving strategic direction, managing clinical development, and serving as a key liaison to the executive leadership team to optimize asset value.
The Associate Director will develop and execute global regulatory strategies for assigned cancer therapy products. They will lead regulatory submission teams, manage health authority interactions, and ensure compliance with global regulatory requirements.
The Principal Statistical Programmer will develop, maintain, and execute SAS programs to analyze and report clinical trial data in compliance with regulatory requirements. They will serve as a primary programmer for clinical trial programs, including ISS/ISE, and collaborate with cross-functional teams to support regulatory and commercial requests.
The Director will manage the qualification, oversight, and ongoing compliance of GxP service providers and suppliers. They will also draft quality agreements and support inspection readiness activities across cross-functional teams.
The Senior Manager will provide GMP quality oversight for investigational programs, including lot review, release activities, and management of quality events like deviations and CAPAs. They will collaborate with cross-functional teams and external partners to ensure compliance with cGMPs and Syndax quality systems.
The Strategic Outsourcing Lead will manage vendor relationships, contracts, and financial oversight across clinical and CMC development programs. They will also lead RFI/RFP activities and ensure compliance with governance processes while collaborating with cross-functional stakeholders.
The Senior Clinical Data Manager will lead clinical data management activities from study start-up through database lock, including the development of eCRFs and data management plans. They will oversee data processing, ensure regulatory compliance, and collaborate with cross-functional teams and external vendors to maintain high-quality data deliverables.
The Director of Clinical Supply Chain will implement and maintain an integrated supply strategy to ensure reliable product supply for global oncology trials. They are responsible for overseeing forecasting, packaging, distribution, and vendor management while leading cross-functional efforts to mitigate supply risks.
