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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 an experienced, motivated individual to serve as an Associate Medical Director (AMD). The Associate Medical Director is responsible for assigned clinical development programs. The AMD will be responsible for supervising clinical trials medical monitoring and will manage contract medical experts and CRO medical monitors assigned to clinical studies. The AMD will assist the Chief Medical Officer and the Senior Director of Clinical R&D with designing and implementing protocol safety assessments, study related safety monitoring, and ongoing analysis of protocol and program safety data. The AMD will report clinical trial safety results to support decision milestones, regulatory and clinical documents, queries and submissions.

The AMD will provide clinical leadership and medical and scientific strategic input for clinical deliverables across studies. The AMD will lead the development of medical safety sections of regulatory documents such as Investigators’ Brochures, safety updates, IND/NDA documents, registration dossiers and responses to Health Authorities. The AMD will support the CMO and Senior Clinical Director in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards and patient advocacy groups) and internal stakeholders (e.g., Clinical and Project Teams and internal decision groups). The AMD will ensure the overall safety of clinical trial subjects and support overall program safety reporting, e.g., Periodic Safety Update Reports (PSURs) and other safety related documents. The AMD will provide expert medical scientific input, as well as contributions to writing of trial related documents (e.g., protocols, case report forms, data monitoring committees, data analysis plans, reports, publications) and present material for trial-related advisory boards, investigators meetings and protocol training meetings. The AMD along with other members of the Clinical R&D team will be responsible for clinical/scientific content of clinical communications and publications. The AMD will cooperate with clinical operations to ensure optimal execution of program Operational Plans including medical and operational support of trials as needed. The AMD will support the Clinical R&D group by providing medical input into protocol and CDP reviews and contributing/driving clinical standard development for programs and new disease areas.

Qualifications/Requirements:

• M.D. degree with American Board of Medical Specialties certification in Neurology.
• Current state license (any state) in good standing a plus
• 3 years clinical trial experience with demonstrated ability to manage several trials in parallel with multidisciplinary trial teams
• Demonstrated ability to establish strong scientific partnership with key investigators thorough knowledge of GCP, clinical trial design, statistics, and regulatory/clinical development process
• Capability to interpret, discuss and present trial data
• Strong interpersonal and communication skills
• Ability to resolve issues with minimal supervision and understand when to escalate
• Excellent scientific writing skills
• Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report safety results effectively

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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