Associate Director Feasibility Lead

Role Summary

The Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility, coordinating data-driven early indication and program assessments, study-level feasibility assessments, country and site identification, recruitment projections, and retention recommendations across all development phases. Partners with key stakeholders within Global Development Operations (GDO), Medical Affairs, Medical, and CROs to enable expedited, predictive delivery for all stages of global feasibility. Ensures standardization of data, tools and processes to inform risk-benefit decision making at TA, program, and study levels. Location: Princeton, NJ; field-based.

Responsibilities

• Accountable for leading and conducting the end-to-end data-driven feasibility process.
• Proactively seeks input from customers, which may include patients, sites and other Genmab functions both in and outside of GDO.
• Responsible for the creation and maintenance 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.
• Key contributor to the study’s operational plan.
• 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.
• Excellent stakeholder management, concise written communication, ability to influence, clearly communicate and collaborate across an increasingly complex matrix environment.
• 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.

Skills

• Data analysis and interpretation for strategic decision making.
• Feasibility study design, development, and validation.
• Cross-functional collaboration and stakeholder management.
• Clinical trial design and execution knowledge.
• Proficiency with MS Office and relevant systems/tools.
• Strong written and verbal English communication.
• Ability to work in a fast-paced, global environment and drive process improvements.

Additional Requirements

• Approximately 5% business travel (overnight) required for internal meetings and congresses.