Clinical Scientist Global Medical Affairs, Neuroscience

job summary: The 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 study protocols and scientifically execute study plans. The incumbent will report to the Global Medical and Scientific Affairs Medical Lead and collaborate closely with the Clinical Scientist Lead for the molecule to execute on the assigned studies. location: Telecommute job type: Contract salary: $98.08 - 120.44 per hour work hours: 9 to 5 education: Bachelors responsibilities: Scientific & 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 studies
• Lead or co-lead the scientific design of the study (objectives, endpoints, protocol content)
• Conduct ongoing clinical data review, data cleaning
• Manage study amendments
• Ensure study level oversight of vendors/CROs, as applicable
• Ensure oversight of study sites
• Review and quality check draft analysis datasets, tables, figures, listings
• Contribute to or lead the CSR, publications, and communication of results
• Ensure compliance with GCP/ICH
• Partner cross-functionally to uphold scientific rigor of study projects
• 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.

qualifications:

• BA/BS or higher degrees in life sciences, preferably in neuroscience
• 5+ years as a Clinical Scientist in the pharmaceutical industry with experience executing global clinical studies (Ph I-Ph IV)
• 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 detail

skills: Neurology, Good Clinical Practice (GCP), Clinical Study Report (CSR), International Council for Harmonization (ICH) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job. Apply tot his job Apply To this Job