Team Head* Clinical Trial Scientists
- Work experience
- Medicine, Pharmacy, Laboratory
- Research, development, teaching
Become a member of the BioNTech Family!
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Team Head* Clinical Trial Scientists
Your main responsibilities are:
- Leads a team that works cross-assets, to perform high quality, timely clinical data review.
- Safeguards the identification of clinical data insights through ongoing patient level review and trend analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle.
- Continuously drives to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. Identifies new ways of working and delivery.
- Drives the planning and implementation of Data Review and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.
- Owns the clinical data review process improvements, for example by implementation of innovative data analysis processes and tools, and their continuous improvement.
- Reviews and supervises the day-to-day work of his line reports, where appropriate. Guarantees a medical check for final release.
- Ensures the team supports and aligns with pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings).
- Drives best practice sharing both within the Clinical Trial Scientist team and beyond. Conducts dedicated training and capability building measures.
- Recruits and establishes the global team of Clinical Trial Scientist by attracting, hiring and retain the best talents. Actively shapes the capabilities of the team by driving for best practice and continuous improvements. Creates an attractive and open working environment.
- Demonstrates a cross-asset mindset that is guided by overarching portfolio strategic considerations.
What you have to offer.
- M.D. or Ph.D with scientific and clinical research background. Expertize in Immuno-Oncology, Oncology and/or Infectious diseases is preferred.
- 8 years+ experience in working on drug development with strong exposure to clinical trial activities incl. data review and day-to-day scientific management of protocol and trials.
- Of which 4+ years plus should be with direct line management and people management accountabilities.
- Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
- Deep experience in liaising with clinical operations as well as with epidemiology on regular basis for efficient clinical trial conduct and for solving any open questions and/ or queries.
- Very strong experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
- Sound familiarization with processes, tools and system for clinical data review; demonstrated experiences in accelerating and upgrading them.
- Ability to strategize clinical activities based on a TPP and CDP and translate into trial designs.
- Experiences with working in a matrix environment (global and cross-functional), including contributing to establishing clarity, structures and processes and driving state of the art collaborations with external and internal partners.
- Good understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
- Strong experience (>4 years) in recruiting and retaining talent, as well as building their capabilities and forming high performance teams.
- Passion to build teams, focus on people management aspects of the role and proven success in building capabilities and talent of the future.
- Effectiveness as a matrix leader, and ability influence on multiple level of the organization. Sound experience in leading teams working on several assets / priorities and ensure appropriate staffing and attention levels. Ability to balance several questions on staffing, by aligning decisions with overarching portfolio priorities.
- Demonstrated proficiency in working under time pressure and applying meaningful prioritization. High proficiency in English (written and spoken); German a plus.
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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