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

BioNTech SE-posted 3 months ago
$210,000 - $310,000/Yr
Full-time • Senior
Remote • Berkeley Heights, NJ
1,001-5,000 employees
Chemical Manufacturing
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As (Senior) Director, Clinical Trials Feasibility, Planning, and Analytics within Global Clinical Development Operations (GCDO), you will provide strategic leadership and oversight for the feasibility assessment, operational planning, and analytical support of global clinical trials across BioNTech's portfolio. In this role you will interact with and influence senior management, cross-functional teams and external partners to deliver options for identification of investigators, developing alternative scenarios to reduce timelines, identify and planning for risks, and suggest recommendations for improved study execution. The strategic impact of this position involves developing predictive models utilizing clinical and real-world evidence to help cross-functional clinical trial teams to develop feasible clinical research protocols. The role is also responsible for forecasting enrollment and tracking performance of ongoing clinical trials and identify execution risks. In addition, this role requires partnering with data suppliers and CROs to enhance BioNTech's ability to support strategic operational choices as well as assessing innovative opportunities for protocol design utilizing the power of big data.

  • 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.
  • Adhere to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).
  • Degree in life sciences, public health, or related field (PhD, PharmD, or MSc preferred).
  • Minimum 12 years (min of 15 years for Sr. Dir) of professional experience, including substantial involvement in clinical operations, feasibility, and planning.
  • 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.
  • Strong analytical skills and proficiency in data visualization and forecasting tools.
  • Ability to analyze complex data and provide simplified actionable insights to drive decision-making.
  • Excellent written and verbal communication skills.
  • Proficiency in using Microsoft software (Word, Excel, PowerPoint, MS Project) and clinical trial analytics tools.
  • Demonstrated self-starter and team player with strong interpersonal skills.
  • Ability to motivate and lead a team, with a focus on talent retention and development.
  • Attention to detail with the ability to recognize problems and offer practical mitigating solutions.
  • Excellent organizational, analytical, and critical thinking skills.
  • Results-oriented mindset, and ability to manage competing priorities at a global level.
  • Willingness to travel as required.
  • Competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience.
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