Location: New Jersey/US/Remote Reporting Line: CEO Industry: Biotechnology (Clinical-stage)
Join us as our Clinical Development Leader, a pivotal role in orchestrating the journey of our novel treatments from research to patients. You'll spearhead multi-functional teams, forge strategic partnerships with hospitals and physicians, and ensure expert oversight of our CROs.
Responsibilities:
Enhance and implement the research-to-market strategy, navigating critical decisions across the entire spectrum.
Provide leadership to dedicated teams encompassing Clinical, Medical, Safety & PV, Data Management, and Quality Management.
Cultivate robust relationships with hospitals and physicians, advocating for the success of our innovative pipeline.
Oversee the management of Contract Research Organizations (CROs), offering expert support and meticulous medical monitoring to ensure the highest standards of performance.
Qualifications:
MD-level hematologist (PhD preferred) with 7+ years in early-phase clinical development, specializing in cellular immunology within Pharma/Biotech.
Proficient in overseeing the entire life cycle management of novel drug development.
Expert in clinical risk management and safety protocols.
Proven track record in team management, with familiarity in relevant functional departments (e.g., clinical, DM, PV, medical).
Well-versed in US FDA regulations, clinical research, GCP, and ICH guidelines; outstanding communicator engaging effectively with crucial stakeholders.