Associate Director of Coding, Data Management
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has one approved oncology precision medicine and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios Pharmaceuticals is searching for a dynamic Associate Director of Coding to join our growing Data Management team. The Associate Director will be responsible for delivery of the highest quality medical coding for individual clinical trials, clinical development programs, and regulatory submissions (Safety regulatory requirements as well as BLA submissions). He or she will be responsible to develop a long term coding and dictionary strategy that will help to ensure that Agios meets industry and quality requirements for clinical trial, safety, and post marketing coding in a growing company. He or she will define and implement coding processes ensuring best practices in medical coding and dictionary management for both clinical trial and Safety coding. He or she will also serve as a subject matter expert for all topics pertaining to the use of medical coding data in statistical analysis, impact assessment, and safety signaling.
Responsible for all medical coding deliverables that support Agios's regulatory commitments including submission of safety data and the preparation of the Integrated Summary of Safety (ISS) component of licensing applications.
Serve as medical coding subject matter expert for DM, Safety, and Biometrics; oversee routine and ad hoc impact analysis with pertinent MDs, in particular those related to bi-annual MedDRA dictionary upversioning; support Safety in the development of expectedness lists for all clinical trial IMP and marketed products.
Partner with Technical Systems and IT counterparts to optimize processes and technology that support efficient dictionary management and oversight of vendor quality.
Responsible for the development, implementation, and ongoing evaluation of Agios coding conventions to ensure consistency and optimize integration capabilities within and across therapeutic areas and Programs.
Develop and maintain strong relationships with vendors performing Clinical trial and Safety Case coding, ensuring high quality deliverables, consistent application of coding conventions, implementation and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary.
Develop and maintain coding and dictionary management processes for Agios in collaboration with key stakeholders.
Review Program and study level clinical trial, SAE, and post marketing coding performed by vendors for quality and consistency.
Bachelor/BSN with 6-10 years of experience in a medical/clinical research environment.
Minimum of 5 years coding experience, minimum of 3 years coding oncology indications (Solid tumor and hematological indications preferred)
Proficiency in the structure, management and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post marketing safety data management)
Experience overseeing vendors performing clinical trial and/or safety coding
Experience developing and maintaining coding processes and conventions
Familiarity with WHO B3/C3 reporting requirements
Knowledge of MedDRA SMQs and ARGUS database
Prior experience in Data Management preferable
Demonstrated ability in strategic thinking, risk assessment, and mitigation
Demonstrated ability in a matrix role management and communication with interdisciplinary teams.
Strong negotiation, conflict resolution and team building skills
Excellent communication and interpersonal skills
Working knowledge of one or more coding and clinical trial data/safety management systems (Oracle Clinical, AERs, Oracle TMS, Medidata, InForm, etc.)
Proficiency with MS Office suite (Word, Excel, Project, Visio) and reporting tools such as Spotfire or JReview.