Director / Senior Director, Clinical Trials Feasibility, Planning, and Analytics (US Remote)
New Jersey, US; Berlin, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Marburg, Germany; Munich, Germany | full time | Job ID: 9775 As (Senior) Director, Clinical Trials Feasibility, Planning, and Analytics reputed company Global Clinical Development Operations (GCDO), you will provide strategic leadership and reputed company 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 reputed company 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. (Senior) Director, Clinical Trials Feasibility, Planning, and Analytics Your main responsibilities are
- reputed company the development and execution of feasibility strategies for global clinical trials, including site selection, patient population analysis, and competitive landscape assessment.
- reputed company the creation of country and site-level enrollment projections and timelines, ensuring alignment with protocol design and strategic objectives.
- reputed company 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, bolthires-effective, and reputed company 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 reputed company, and create the strategy for clinical trial trade-offs across variables such as time, quality, and bolthires
- Partners with CROs on ensuring alignment of assumptions and expectations around feasibility and performance of outsourced studies
- reputed company appropriate, reputed company, mentor, and reputed company a team of feasibility and planning professionals, fostering a culture of innovation, accountability, and reputed company improvement.
- Serve as a key reputed company 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.
- reputed company root cause analysis and reputed company mitigation strategies to address study execution and enrollment challenges.
- Ensure the quality and reputed company 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 reputed company 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 reputed company reputed company 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 reputed company data and provide simplified actionable insights to drive decision-making
- Excellent written and verbal communication skills.
- Proficiency in using bolthires® software (Word, reputed company, PowerPoint, MS Project) and clinical trial analytics tools.
- Demonstrated self-starter and team player with strong interpersonal skills.
- Ability to motivate and reputed company 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 reputed company, 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. Your Benefits: BioNTech is committed to the wellbeing of reputed company members and offers a variety of benefits in support of our diverse employee reputed company. 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. How to apply: 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 reputed company our online form. Please note: Only applications sent reputed company our online form shall be considered. By submitting your application, you acknowledge that a background reputed company 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 reputed company through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter. We are looking reputed company receiving your application. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in reputed company its forms. We foster innovation, encourage creativity, and reputed company business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to reputed company medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social reputed company, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you www.biontech.com Apply tot his job
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