Head of Clinical development-Medical Director (neurodegenerative)

The position requires expertise in clinical development, with a strong understanding of the particular challenges of neurodegenerative disorders, as well as outstanding clinical and scientific knowledge applicable to clinical research. The role includes significant external interaction, building relationships with study sites, development partners, and the medical/scientific community. KEY RESPONSIBILITIES Clinical Trial Design and Execution •Lead, design, and coordinate activities to support Phase II/III clinical programs in Alzheimer’s disease and dementia with Lewy Bodies. •Design and direct execution of clinical development research studies to evaluate therapies for efficacy, safety, clinical pharmacology, and pharmacokinetics. •Direct all aspects of clinical trials including study concept, protocol and timeline development, site identification, investigator meetings, medical monitoring, safety, data review and interpretation. •Develop unique and innovative clinical strategies to improve clinical development through faster studies and/or novel outcome measures. •Serve as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, KOLs, advisory boards), internal stakeholders (e.g., R as appropriate, author scientific papers for journal publication. QUALIFICATION S Education NDA experience is a plus •Industry experience to include responsibility as a Senior Director or Medical Director for designing, leading, and managing clinical studies •Familiarity with the requirements of a drug safety program (extensive pharmacovigilance experience is not required) Skills