The Clinical Trial Manager oversees the strategic implementation and execution of clinical trials from start-up to close-out. They manage CROs, study vendors, and sites while ensuring compliance with regulatory requirements and internal SOPs.
The Director of IT will serve as the strategic leader for GxP-regulated business systems supporting R&D, clinical operations, and quality functions. They are responsible for the implementation, validation, and maintenance of scientific systems while ensuring compliance and scalability for pivotal-stage drug development.
The Sr. Director will lead global regulatory strategies for late-stage Skeletal Dysplasia programs, ensuring alignment with registration and commercialization objectives. They will manage interactions with global health authorities and provide strategic guidance to cross-functional teams to support accelerated development pathways.
The Senior Director will build and lead the GMP QA function, overseeing outsourced drug substance and product manufacturing. They are responsible for batch disposition, inspection readiness, and ensuring compliance with global regulatory requirements.
Lead statistical programming activities for clinical studies and development programs from startup through regulatory submission. Develop and validate SDTM, ADaM, and TLFs while providing technical oversight to internal staff and CROs.
The VP of Medical Affairs will lead the strategic development and execution of medical affairs activities, including scientific communications and KOL engagement. They will partner with cross-functional teams to ensure scientific integrity and drive evidence generation across the oncology portfolio.
The Senior Medical Science Liaison serves as a scientific expert, driving clinical trial support and fostering relationships with Key Opinion Leaders in oncology and urology. They are responsible for synthesizing field insights and supporting medical education initiatives to advance the company's pipeline programs.
