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

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

BiontechGaithersburg, MD, US
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Director / Senior Director, Clinical Trials Feasibility, Planning, and Analytics

New Jersey, US; Berlin, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Marburg, Germany; Munich, Germany | full time

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.

Your main responsibilities are :

  • 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.
  • Partners 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)

What you have to offer :

  • 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. 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.
  • 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.
  • Expected Pay Ranges (US) : Director - $210000 / year to $260000 / year, Senior Director - $250000 / year to $310000 / year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).

    Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

    BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience.

    Note : The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

    Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

    Please note :

    Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

    We are looking forward receiving your application.

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