Senior Clinical Scientist/Clinical Scientist
Job Category:Clinical Development
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
DNS is seeking motivated experienced clinical research scientists to participate in all aspects of planning, implementing, managing and reporting of clinical studies, under the supervision of the department director, or designee. These individuals will provide key overall scientific and/or logistical support to clinical development programs in general. Some positions will require thorough knowledge/experience in the assessment of neurocognitive functioning.
Responsibilities include, but are not limited to:
• Assisting in or designing, authoring and/or reviewing clinical study synopses, protocols, amendments, study reports and other study-related documents
• Preparing clinical sections of registration documents (e.g., INDs, IND annual reports, NDAs); providing input on preparation of other key clinical documents, e.g.: Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling
• Assisting in database finalization, reviewing of study results and results interpretation
• Establishing and maintaining peer-peer relationships with leading physicians and therapeutic area thought leaders at major academic institutions and clinics, both domestic and international
• In collaboration with other team members (e.g., Clinical Operations, Data Management), assisting in monitoring clinical trial conduct/status
• Assisting in identifying/evaluating vendors
• Assisting in planning and conduct of investigator meetings
• Assisting with fielding site questions during conduct of trials as needed
• Minimum 3 years or 5 years pharmaceutical industry clinical research experience for the Clinical Scientist or Senior Clinical Scientist positions, respectively (other relevant research experience in the pharmaceutical industry may be considered)
• Thorough working knowledge/understanding of clinical trial design, methodology and statistical concepts
• Thorough working knowledge of assessment of brain-behavior relationships and assessment of cognition in patients with psychiatric and/or neurologic disorders will be required for some positions
• Bachelors level degree in a scientific discipline required (graduate level degree or other advanced scientific training in a scientific or health-related discipline preferred, e.g., clinical pharmacy, pharmacology, clinical pharmacokinetics, nursing, psychology, physical therapy/rehabilitation science, neuroscience/cognitive science)
• Experience in CNS-related clinical research and development highly preferred
• Phase I-IIb clinical trial experience preferred
• Working knowledge of the IND/NDA process
• In depth knowledge of GCP/ICH guidelines
• Strong written and verbal communication skills as well as proven ability to interact with different functional groups
• Good organizational, time management and interpersonal skills, proficiency in computer and software skills
• Self-motivated with the ability to influence others
• Ability to multitask
• Result driven with the ability to demonstrate time management and project planning
• Able to work on site and must be legally authorized to be employed in the United States.
• Participate in preparation of scientific publications (i.e., planning, writing, editing, reviewing and finalization), including and not limited to, abstracts, posters, manuscripts and presentations) as needed
• Willingness and ability to travel (up to 25% of the time)
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.