The contractor will oversee the entire contract lifecycle, including drafting, reviewing, and negotiating various corporate and clinical agreements. They will also manage the internal contract database and implement strategies to improve contract management efficiency.
The Associate Director provides strategic and operational leadership for pharmaceutical packaging and labeling activities throughout the product lifecycle. They are responsible for managing external manufacturing partners, ensuring regulatory compliance, and overseeing production campaigns to maintain reliable product supply.
The Associate Director of Logistics leads end-to-end pharmaceutical logistics operations, including transportation, warehousing, and distribution across domestic and international markets. They ensure compliance with regulatory standards such as GDP and GMP while managing serialization data and optimizing supply chain performance.
The Senior Director of Alliance Management is responsible for managing, coordinating, and optimizing strategic partnerships to ensure the successful execution of development and commercialization plans. This role involves leading governance committees, facilitating decision-making, and liaising across internal departments to ensure contract milestones and financial objectives are met.
The Senior Director will lead integrated supply planning, network strategy, and supply risk management across clinical and commercial supply chains. They will align demand forecasts, manufacturing plans, and inventory strategies with business objectives while chairing production control meetings to ensure supply reliability.
The Senior Director will lead business relationship management and operational oversight of the global contract development and manufacturing organization network. They will partner with technical and quality teams to ensure reliable, compliant, and cost-effective drug substance and drug product manufacturing.
The Vice President of Market Access will lead the development and execution of comprehensive market access strategies for the company's hematology-oncology portfolio. This role involves managing payer marketing, pricing, contracting, and patient support services while collaborating with cross-functional teams to ensure long-term franchise growth.
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 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 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 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.
