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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!


Job Summary:

DNS is seeking a motivated experienced clinical research professional to serve as Associate Director in the Department of Clinical Research and Development. The successful candidate will participate in all aspects of planning, implementing, managing and reporting of clinical studies, under the supervision of the department director, or designee. This individual will also serve as Project Leader on Development Project Teams as assigned, in addition to providing key overall scientific and/or logistical support to clinical development programs in general.

Responsibilities include, but are not limited to:

• Design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents
• Lead multidisciplinary Development Project Teams
• Lead a specific Clinical R&D function, group or department (e.g., Phase 1/Clinical Pharmacology) as assigned and as opportunities arise
• Prepare clinical sections of registration documents (e.g., INDs, IND annual reports, NDAs); provide input on preparation of other key clinical documents, e.g.: Investigator’s Brochures, Statistical Analysis Plans, Product Development Plans
• Assist in database finalization, review of study results and results interpretation
• Establish and maintain peer-peer relationships with leading physicians and therapeutic area thought leaders at major academic institutions and clinics, both domestic and international
• Assist with preparations for advisory board and regulatory agency meetings as needed
• May contribute to scientific/clinical evaluation of potential in-licensing candidates and due-diligence activities, as needed
• In collaboration with other team members (e.g., Clinical Operations, Data Management), assist in monitoring clinical trial conduct/status
• Assist in identifying/evaluating vendors
• Assist in planning and conduct of investigator meetings
• Assist with fielding site questions during conduct of trials as needed
• Provide supervision, oversight and direction to DNS clinical research department staff, as assigned

Qualifications/Requirements:

• Minimum 10 years clinical research experience, including 5 years pharmaceutical industry clinical research experience (other relevant research experience in the pharmaceutical industry may be considered)
• Thorough working knowledge/understanding of clinical trial design, methodology and statistical concepts
• Experience leading multidisciplinary drug development teams strongly preferred
• 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
• Graduate level degree in a scientific discipline, or other advanced scientific training in a scientific or health-related discipline strongly preferred (e.g., clinical pharmacy, pharmacology, clinical pharmacokinetics, biological science, nursing, psychology, physical therapy/rehabilitation science, neuroscience/cognitive science)
• Experience in CNS-related clinical research and development highly preferred
• Knowledge/experience in the assessment of neurocognitive functioning preferred.
• Phase I-IIb clinical trial experience required; additional Phase 3-4 experience, while not required, is preferred
• Hands on experience participating in IND/NDA preparation
• In depth knowledge of GCP/ICH guidelines
• Strong written and verbal communication skills as well as proven ability to interact with different functional groups
• Previous supervisory/managerial experience preferred
• Experience in reviewing and interpreting preclinical data strongly preferred
• 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)

Benefits:

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.

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