Director/Associate Director

Job Description

Job Description:

This role reports through the Clinical function which provides scientific expertise necessary to design, implement and interpret data from clinical studies. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies in collaboration with Clinical Operations. This role will be responsible for the scientific aspects global clinical trial delivery including protocol design and writing, analysis of data, management and reporting of trials in accordance with company plans/objectives, ICH-GCP, country requirements and company standard operating procedures. Specifically, this includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, supporting site selection, data review and writing/reviewing the clinical study report, for one or more clinical trials. Other important tasks will be supporting the Chief Medical Officer and Head of Operations planning, publication strategy and other tasks.

Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.

Key Responsibilities:

Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.

Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.

Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, statistical analysis plans, study plans, CSRs.

Evaluate innovative trial designs in collaboration with Head of Operations and Chief Medical Officer

In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plans to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.

Co-lead the cross-functional clinical trial working groups, collaborating with Clinical Operations and extern functions to drive delivery and facilitate issue resolution.

Collaborate with Clinical Operations to plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally.

Collaborate with other Corbus functions to support effective study specific vendor interactions

Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members

Drive the review, analysis, and interpretation of study results ensuring that accurate conclusions are drawn and working with our CMO to appropriately contextualize

Identify study and program-wide issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution.

Conduct literature reviews as needed for the interpretation of study data and development of next steps.

Works closely with the CMO to ensure they are informed of pertinent study information, including but not limited to safety and efficacy data.

Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports (DSURs) and periodic updates, and clinical sections of regulatory submissions to support product approvals.

Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules, support stratification biomarkers.

In conjunction with the CMO, develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.