The Senior Director provides strategic and operational leadership for the clinical data technology ecosystem, overseeing system governance, architecture, and vendor management. They lead a team responsible for platform configuration and integration while ensuring compliance with regulatory standards and supporting cross-functional study deliverables.
The Associate Director manages integrated clinical and commercial product planning, including generating master production schedules and allocating bulk materials across global CMOs. They are responsible for monitoring global stock levels, setting safety stock guidelines, and ensuring operational continuity under GxP regulations.
The Associate Director will support and contribute to global regulatory strategies to expedite development and mitigate risks for immunology therapies. They will also lead the preparation and coordination of regulatory documents for global health authority submissions while collaborating with cross-functional teams.
Oversee and manage quality control operations to ensure product standards are met. Lead the QC team in maintaining rigorous testing and compliance protocols.
Lead the biostatistics strategy and tactical execution for multiple development programs in a clinical-stage immunology company. Provide rigorous statistical input for clinical development plans, regulatory submissions, and the management of study biostatisticians.
The Director, Medical Science Liaison is responsible for establishing and maintaining scientific exchange with key opinion leaders, healthcare professionals, and clinical investigators. They will provide clinical support for ongoing trials, collect medical insights, and collaborate with cross-functional teams to ensure accurate scientific information exchange.
