Position Overview

We are seeking a Senior Clinical Scientist to join our Clinical team to help with the design and execution of clinical development plans for our lead programs (i.e., GM1 gangliosidosis and Frontotemporal Dementia or FTD) supporting clinical studies across all phases of drug development.  The ideal individual will have a strong scientific and clinical research background and be able to assume a lead role in the planning and conduct of ongoing and future clinical trials. They will work within a multi-disciplinary, matrix team ensuring that clinical, scientific, and regulatory issues are appropriately considered with respect to highly complex clinical studies.

Key Responsibilities

• Under the supervision of the Clinical Development physicians, responsible for the design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the trial conduct; contribute to the development of clinical protocols including definition of efficacy and safety endpoints
• Work closely with Clinical Development physicians, Clinical Operations and Functional leads to provide scientific support, conduct clinical data review and data analysis, help evaluate and identify key clinical and pre-clinical data required for decisions around medicine development as well as define and mitigate key development risks of a compound
• Serves as a key cross functional collaborator; represents the Clinical Scientist function on Development Teams
• Reviews and assesses overall safety information in conjunction with Clinical Lead, Pharmacovigilance and Medical Monitor
• Support global regulatory strategy development and contribute to the development of briefing documents including clinical elements of regulatory submission documents as well as participate in Agency interactions
• Prepare data and contribute to scientific publications including posters, presentations, abstracts and manuscripts
• Facilitate decision-making both within the project team and with external stakeholders

Requirements / Qualifications

• Advanced degree in life sciences (Pharm D, MS, PhD, or equivalent)
• Minimum of 5-8 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
• Strong scientific background with experience in rare disease and/or gene therapy; expertise in neurology/neurodegenerative diseases is preferred
• Comprehensive understanding of the drug development process in all phases of development (phase I-III)
• Strong analytical and strategic thinking skills; ability to proactively predict issues and solve problems
• Ability to work independently and within team environments with skills to drive decision-making within a multi-disciplinary, matrixed team
• Excellent written and oral communication skills
• Strong knowledge of GCP, ICH, and relevant regulatory requirements
• Comfortable working in a flexible, dynamically changing and challenging environment
• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) and in the use of industry-standard software (e.g., electronic data capture systems) and proficient in data analysis software and data presentation
• Ability and willingness to travel as needed