A services organization in New Jersey is actively seeking a new Associate Director / Feasibility Lead to join their growing team. In this role, the Feasibility Lead will be responsible for supporting through the coordination and development of data-driven early indication and program assessments, study-level feasibility assessments, robust country and site identification, support of DEI (as applicable), recruitment projections, and any retention recommendations, across all phases of development.
This role is offered in a fully remote capacity, supporting on EST hours.
Responsibilities:
Leads and conducts the end-to-end data-driven feasibility process Creates and maintains of study-level patient enrolment forecast based on final operational plan approval and final feasibility. KPIs developed and shared across the study team as part of year end objectives Point of contact for assigned program and study-level feasibilities, leading cross functional teams to develop, validate and refine allocation strategy, inclusive of timelines, scenarios, and risk mitigation plans Identifies and resolves events in the indication landscape (e.g. competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program Actively engages in continual process improvement; gathers cross-functional feedback and depending on business needs, this position may take leadership and/or will participate in initiatives that are at the intersection of technology, process and development experience Qualifications:
Minimum 5 years of direct feasibility experience in the pharmaceutical/CRO/biotech industry Proven experience in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans aligned to the commercial and regulatory objectives. Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study. Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, including health authority guidelines Experience with MS Office and other (relevant) systems/tools. Excellent communication skills in English, both verbal and written.
This role is offered in a fully remote capacity, supporting on EST hours.
Responsibilities:
Leads and conducts the end-to-end data-driven feasibility process Creates and maintains of study-level patient enrolment forecast based on final operational plan approval and final feasibility. KPIs developed and shared across the study team as part of year end objectives Point of contact for assigned program and study-level feasibilities, leading cross functional teams to develop, validate and refine allocation strategy, inclusive of timelines, scenarios, and risk mitigation plans Identifies and resolves events in the indication landscape (e.g. competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program Actively engages in continual process improvement; gathers cross-functional feedback and depending on business needs, this position may take leadership and/or will participate in initiatives that are at the intersection of technology, process and development experience Qualifications:
Minimum 5 years of direct feasibility experience in the pharmaceutical/CRO/biotech industry Proven experience in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans aligned to the commercial and regulatory objectives. Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study. Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, including health authority guidelines Experience with MS Office and other (relevant) systems/tools. Excellent communication skills in English, both verbal and written.