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

BioNTech•Berkeley Heights, NJ

5d•Remote

About The Position

As Director of Clinical Trial Feasibility, Planning, and Analytics within Global Clinical Operations (GCO), you will play a pivotal role in shaping the future of clinical trials at BioNTech. Your work will directly contribute to optimizing operational planning and analytical support for global trials, ensuring alignment with our mission to revolutionize medicine through cutting-edge science. Collaborating closely with cross-functional teams and external partners, you will lead feasibility assessments, develop predictive models using clinical and real-world evidence, forecast enrollment timelines, and identify risks to improve study execution. This role is key in advancing BioNTech’s ability to support strategic decisions while exploring innovative opportunities for protocol design using big data.

Requirements

Degree in life sciences or public health (PhD/PharmD/MSc preferred)
Minimum 10 years of experience in global pharmaceutical or biotech environments with expertise in feasibility planning
Proven ability to lead within matrixed teams and manage competing priorities globally
Strong analytical skills with proficiency in data visualization tools (e.g., Microsoft® Word, Excel, PowerPoint)
Excellent communication skills complemented by stakeholder management abilities
Results-oriented mindset coupled with attention to detail
Willingness to travel as required

Responsibilities

Lead feasibility assessments for global clinical trials, including site selection, patient population analysis, and competitive landscape assessment.
Develop country and site-level enrollment projections and timelines, ensuring alignment with protocol design and core project team objectives.
Build and maintain forecasting models to support scenario planning, resource allocation, and risk mitigation across the clinical portfolio.
Provide operational input during the protocol design phase, ensuring trials are executable, cost-effective, and aligned with core project team objectives.
Lead the adoption of advanced analytics, real-world data, and predictive modeling to inform feasibility and planning decisions.
Lead 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 advise cross-functional teams on clinical trial trade-offs across variables such as time, quality, and cost
Partners with CROs on ensuring alignment of assumptions and expectations around feasibility and performance of outsourced studies
Drive the evolution of BioNTech’s feasibility, planning, and analytics capabilities, strengthening internal ownership while optimizing the use of external partners
Establish and embed fit‑for‑purpose, cost-effective and scalable feasibility and analytics approaches that enhance internal decision‑making
Serve as a key point of contact for clinical 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.
Participate in 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.
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)