Join a global team of experts as a Clinical Scientist in Neuroscience, where you will play a pivotal role in shaping the post-approval landscape and lifecycle management for innovative neurological assets. Reports into a Senior Clinical Scientist; ideal for a mid-level professional looking to execute high-impact Phase IV programs-from initial protocol development through data interpretation and high-impact publication-with a particular emphasis on advancing treatments within the epilepsy space. Primary focus is on Phase IV evidence generation and post-marketing clinical study execution. You will serve as a key scientific voice, collaborating cross-functionally with HEOR, Regulatory, and Clinical Development teams to translate clinical data into actionable insights that support the safe and effective use of products worldwide. Engaging directly with global Key Opinion Leaders and participating in international congresses, you will help define the scientific narrative and evidence generation strategy for the portfolio. If you are a dedicated scientist with 5-10 years of industry experience and a deep passion for neuroscience, this long-term remote contract provides an exceptional platform to drive scientific excellence and improve patient outcomes on a global scale.
Shift: Monday - Friday (Standard First Shift Hours)
location: Telecommute
job type: Contract
salary: $98 - 120 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
- Provide medical and scientific data oversight, including trend analysis and medical data cleaning, to ensure the scientific integrity of the study.
- 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
- Act as the primary scientific point of contact for internal stakeholders, ensuring data interpretation aligns with both commercial and medical strategy.
- 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.
- 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.
- 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.
- 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.
- 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:
Required:
- BA/BS or higher degrees in life sciences with 5-10 years of dedicated industry experience within a Global Medical Affairs (GMA) function at a mid-to-large scale pharmaceutical sponsor.
- Expertise in Phase IV study design, including registries and observational research; experience with IITs is secondary to sponsor-led late-phase strategy.
- Prior experience in compliance with GCP/ICH within the context of global post-approval trial execution.
- Direct experience in clinical data interpretation, scientific narrative development, and authoring clinical contributions for CSRs/Protocols.
- 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
- A degree within a Neuroscience
- Experience with Epilepsy.
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 HRsupport@randstadusa.com.
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.
