Adverum Biotechnologies
Clinical Scientist/Senior (Contract)
Redwood City, CA · Senior
Sponsorship not specifiedDetected 147 days ago
GCPData AnalysisStatisticsExcelRecruitingClinical TrialsClinical ResearchCRISPRResearchExperimental DesignCommunicationCollaborationProblem SolvingCritical ThinkingWritingAdaptabilityMicrosoft Office
About the role
- Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is looking to bring on board a Clinical Scientist/Senior (Contract).
- Contract duration: 6-12 months Note to Recruiters and Agencies All recruiter and agency inquiries must go through Adverum's internal Talent Acquisition team.
- Unsolicited resumes sent to Adverum will be considered Adverum's property.
Responsibilities
- Support the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
- Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
- Support cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
- Engages clinical trial vendors to support study start-up activities in line with the clinical trial design
- Collaborate on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
- Support clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- This role will support the assigned Clinical Trial Lead with the design and execution of key elements of the Clinical Development Plan (clinical study or studies) with minimal to moderate level of supervision.
- This includes activities relating to study design, data generation and validation and data analysis and interpretation.
Nice to have
- MD, PhD, OD, PharmD with ophthalmology experience, preferably including retina experience required.
- Gene Therapy experience also preferred.
- 5-7 years of experience in a clinical research-related role.
- 3-5 years' experience in a Clinical science/development role preferred.
- Knowledge of gene and ocular therapies preferred
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Previous experience working with CROs and other vendors/suppliers preferred
- Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred
Benefits
- Proficient in Medical Terminology and medical writing skills
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
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