Director / Senior Director, Clinical Trials Feasibility, Planning, and Analytics (US Remote)

Role Summary

As (Senior) Director, Clinical Trials Feasibility, Planning, and Analytics within Global Clinical Development Operations (GCDO), you will provide strategic leadership and oversight for feasibility assessment, operational planning, and analytical support of global clinical trials across BioNTech’s portfolio. You will interact with senior management, cross-functional teams, and external partners to identify investigators, develop alternative timelines to reduce study durations, assess risks, and recommend actions to improve trial execution. The role involves building predictive models using clinical and real-world data to inform protocol feasibility, forecasting enrollment, tracking trial performance, and partnering with data suppliers and CROs to enable data-driven operational decisions and explore innovative protocol designs leveraging big data. You will also lead and mentor a team, and serve as a senior advisor to leadership on feasibility, planning, and analytics matters.

Responsibilities

• Lead the development and execution of feasibility strategies for global clinical trials, including site selection, patient population analysis, and competitive landscape assessment.
• Lead the creation of country and site-level enrollment projections and timelines, ensuring alignment with protocol design and strategic objectives.
• Develop and maintain forecasting models to support scenario planning, resource allocation, and risk mitigation across the clinical portfolio.
• Provide strategic operational input during the protocol design phase, ensuring trials are executable, cost-effective, and aligned with business priorities.
• Champion the use of advanced analytics, real-world data, and predictive modeling to inform feasibility and planning decisions.
• Drive the implementation and optimization of digital tools and platforms to enhance planning accuracy and efficiency.
• Track clinical trial performance against expectations, identify areas for potential intervention, and create the strategy for clinical trial trade-offs across variables such as time, quality, and cost.
• Partner with CROs on ensuring alignment of assumptions and expectations around feasibility and performance of outsourced studies.
• When appropriate, lead, mentor, and develop a team of feasibility and planning professionals, fostering a culture of innovation, accountability, and continuous improvement.
• Serve as a key point of contact for senior leadership on trial feasibility, planning, and analysis matters.
• Collaborate with peers in Clinical Operations and cross-functionally with Clinical Procurement, Vendor Management, Clinical Development, Medical Affairs, Regulatory and Project Management to support budgeting, resource planning, and trial prioritization.
• Perform root cause analysis and develop mitigation strategies to address study execution and enrollment challenges.
• Ensure the quality and integrity of feasibility assessments and operational plans, actively identifying and managing internal and external risks.
• Promote the profile and credibility of the department with internal and external stakeholders, including hospitals, investigators, and industry groups.
• Support the QA team during internal audits, vendor audits, and/or hosting inspections as required.
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).

Skills

• Advanced analytics, real-world data, and predictive modeling to inform feasibility and planning decisions.
• Strong analytical skills and proficiency in data visualization and forecasting tools.
• Proficiency with Microsoft software and clinical trial analytics tools.
• Experience driving cross-functional collaboration and stakeholder management.
• Excellent written and verbal communication skills and ability to present complex data clearly.
• Self-starter with strong interpersonal skills and ability to lead in a matrixed environment.

Qualifications

• Minimum 12 years (minimum 15 years for Senior Director) of professional experience, including substantial involvement in clinical operations, feasibility, and planning. Early career experience in other industries is welcome where transferable data analysis skills have been developed.
• Proven leadership experience in a global pharmaceutical, biotech, or CRO environment.
• Proven ability to lead within a matrixed team.
• Deep understanding of clinical trial design, regulatory requirements, and global site landscapes.
• Excellent organizational, analytical, and critical thinking skills.
• Results-oriented mindset, and ability to manage competing priorities at a global level.

Education

• Degree in life sciences, public health, or related field (PhD, PharmD, or MSc preferred).

Additional Requirements

• Willingness to travel as required.