Clinical Scientist Global Medical Affairs, Neuroscience
Pay range: 110-125/hrdepending on experienceThe Clinical Scientist, Neuroscience will support post approval clinical and scientific activities within Global Medical and Scientific Affairs (GMSA) team, serving as a key scientific expert for assigned neuroscience assets. This role focuses on scientific execution of evidence generation projects, scientific communication, and cross functional collaboration to support the safe and effective use of approved products and lifecycle management initiatives. The Clinical Scientist will partner closely with GMSA, Clinical Development, HEOR, Pharmacovigilance, Regulatory, and Commercial colleagues to translate data into meaningful scientific insights for internal and external stakeholders.They are expected to help develop and design post-approval research studies, lead development of the protocol and scientifically execute on a study protocol. The incumbent will report to the Global Medical and Scientific Affairs Medical Lead and collaborate closely with the Clinical Scientist Lead forthe molecule to execute on the assigned studies.Assumes lead role in various clinical research projects. Proposes, plans, organizes and executes experiments and research. Secures grants and funding for research and is responsible for controlling budgets. Summarizes findings in reports and communicates results. Interacts with other scientists within and outside of the organization. Provides recommendations that influence extensive clinical research activities. Requires an advanced degree and typically requires 4 -7 years of related experience.Essential FunctionsScientific & Medical Leadership Serve as a scientific expert for assigned post approval neuroscience products and indications, with deep understanding of disease state, mechanism of action, and evolving treatment landscape. Experience in epilepsy is highly preferred. Accountable for the design and scientific execution of the assigned clinical studyLead or co-lead the scientific design of the study (objectives, endpoints, protocol content)Ensure the scientific integrity of the study throughout executionScientific aspects of data review, interpretation and issue resolutionContribute to or lead the CSR, publications, and communication of resultsEnsure compliance with GCP/ICHPartner cross-functionally to uphold scientific rigor Ability to analyze, interpret and contextualize complex clinical and real-world data for diverse audiences Contribute to the development and execution of the GMSA evidence generation plan, including post marketing studies, investigator initiated studies, and real world evidence initiatives.Evidence Generation & Lifecycle Management Provide scientific input into the design, conduct, analysis, and interpretation of post approval clinical studies, registries, and observational research. Collaborate with internal partners and external investigators on scientific feasibility and provide ongoing scientific study support.Scientific Communications Lead or contribute to the development of scientific materials, including but not limited to medical decks, study related documents (e.g. ICF), FAQs, training materials, publications, abstracts, and congress content. Train personnel on all aspects of the study protocol Communicate issues/risks to the cross-functional study team when appropriate Communicate study findings to leadership, publication team and other key stakeholders, both internally and externally. Support publication planning and execution, including author collaboration, data review, and compliance with publication standards. Ensure scientific accuracy, balance, and compliance across all GMSA deliverables.Cross Functional Collaboration Provide clinical content for a variety of cross-functional clinical documents such as informed consent forms, regulatory clinical documents, annual/periodic reports and clinical study reports. Collaborate with Medical FMT to understand data gaps and needs Collaborate with Clinical Development, Safety, Regulatory, and HEOR teams to ensure alignment across post approval activities. Provide scientific input to internal governance committees, including medical review and evidence generation forums.External Engagement Support engagement with key opinion leaders (KOLs), investigators, and external experts in neuroscience. Participate in advisory boards, steering committee meetings, medical team meetings and congress activities as a scientific representative of Global Medical and Scientific Affairs. Stay current on emerging science, guidelines, and competitive intelligence within the neuroscience therapeutic area.Required Knowledge, Skills, And Abilities 5+ years as a Clinical Scientist in the pharmaceutical industry with experience executing global clinical studies (PhI-PhIV) Strong working knowledge of Good Clinical Practice (GCP), ICH and applicable regulatory requirements governing post-approval research and Medical Affairs activities. Deep technical and neuroscience therapeutic expertise and knowledge (e.g. neurology, psychiatry, neurodegeneration, movement disorders). Solid understanding of clinical study design, biostatistics, and post-marketing research methodologies Excellent scientific writing and communication skills; experience with protocols, CSRs and publications Collaborative team player, with proven ability to work effectively in a matrix, cross-functional environment Excellent verbal and written communication skills Excellent presentation skills, with ability to summarize data catering to audience (from lay person to senior leadership) High level of scientific integrity and attention to detailRequired/Preferred Education And LicensesBA/BS or higher degrees in life sciences, preferably in neuroscience