Drives strategy and provide insight for potential new clinical programs and projects based on medical need and development requirements; leads the design of clinical programs and study protocols and contributes to their timely execution of all neuroscience clinical programs; Organizes and executes clinical advisory boards to enhance and focus scientific contents of the ne

Manage and lead the patient safety and pharmacovigilance function including oversight for activities, operations, and continued evolution toward a best in class organization. Leadership of patient safety for our products, including provision of a clearly defined safety strategy, oversight of product emerging safety profiles including signal detection/evaluation from all d

Execute department operational, technology, and financial tasks and projects and corporate governance, licensing, and permit matters. Other duties and special projects as assigned. This is a hybrid work arrangement with 3 days in office. Education and Experience Requirements Bachelor's degree 5+ years of relevant experience in a fast paced, dynamic law firm or in house le

In collaboration with regulatory leads and cross functional CMC Teams, lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries. Incorporate regulatory strategy and well positioned content into high quality submissions to suppo

Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con

Lead the statistical strategy for projects and participate as a core member on clinical study teams. Be accountable and responsible for the statistical design, analysis plans, reporting (including development of ADaM specifications/datasets) and interpretation of Phase 1 4 clinical trials including integrated analyses across trials. Initiate, drive and implement novel met

Clinical Development Represent PV during internal cross functional and external vendor meetings. Independently provide input to clinical development planning activities. Ensure consistent safety monitoring approach in line with industry standards. Lease with colleagues across functions to support collaborative workflows. Clinical Safety Proactively review clinical safety