Aevi Genomic Medicine, Inc. is dedicated to translating genetic discoveries into novel therapies. Driven by a commitment to patients, and guided by genomic insights, we strive to help patients navigate through the complexities of their disease. If you are looking for an opportunity to be part of building a fast-paced, collaborative, scientifically-disciplined team, then this is a great time to join Aevi to make a difference in the lives of children and adults with pediatric-onset diseases.
Director, Clinical Operations
|Title:||Director, Clinical Operations|
|Department:||Research and Development|
Responsible for the planning, implementation, execution and management of clinical research studies. Manages clinical outsourcing to CROs and other vendors such as IXRS, labs, IRBs, etc. Ability to author, review and approve various study related documents. Evaluates issues, interprets data, suggests and implements solutions. Responsible for the financial and budgetary planning and tracking of assigned studies.
- Represents and leads the study team to design (as appropriate), develop and deliver the clinical study to agreed upon timelines.
- Ability to integrate and summarize medical/scientific concepts in protocols and other documents.
- Collaborates with project physician and statistician on clinical trial designs.
- Ability to author synopses, protocols, ICFs, sections of Investigator Brochures; reviews and approves study related plans.
- Develops and executes complex study plans in one or more clinical study(ies).
- Responsible for the clinical review and approval of Case Report Forms and provides clinical input into corresponding completion guidelines.
- Responsible for identification and selection of investigator sites.
- Responsible for planning and conducting investigator’s meetings. Presents information at the investigator meeting.
- Provides input and coordinates the on-schedule delivery of clinical trial supplies in collaboration with Clinical Supply representative.
- Collaborates with Clinical Supply representative on the selection and management of IXRS vendor.
- Leads team through selection process and provides input into contracts, change orders, and/or work orders.
- Requests and critically evaluates proposals and change orders from CROs and vendors.
- Develops and monitors budget for assigned study(ies).
- Contributes to negotiating budgets and contracts with CROs, vendors and/or investigative sites (as applicable).
- Trains and manages CRO / other clinical vendor activities to ensure the quality consistent with company and regulatory requirements.
- Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
- Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
- Manages escalation of study related isses and communicates as appropriate with management and other R&D functions.
- Ability to anticipate potential study issues and prepare contingency plans with minimal oversight.
- Responsible reviewing monitoring reports relating to the study.
- Evaluates CRO and vendor performance for future work.
- Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.
- Significant clinical research experience (10+ years) with evidence of increasing responsibility within a pharmceutical company or CRO or similar organization and experience leading cross functional teams.
- Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
- Experience of regulatory submissions is preferred, but not required.
Aevi Genomic Medicine, Inc. offers its employees a competitive benefits and compensation plan.
Aevi Genomic Medicine, Inc. is an Equal Opportunity Employer.