Associate Director, Clinical Research and Development - San Diego, CA | Biospace
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Associate Director, Clinical Research and Development

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
4/26/2017
Position Type:
Full time
Job Code:
17-028 #802661
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Clinical Research, Neurosciences, Pharmacokinetics, Pharmacology,

Job Description

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

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)