Director / Associate Director, Clinical Science

London, United Kingdom | full time | Job ID: 11593

Your Contribution:

- Contribute to designing clinical trials to evaluate the safety and efficacy of investigational drugs. This includes developing the study protocol, identifying patient populations, selecting study endpoints, and determining theappropriate study design.

- Responsible for clinical development oversight of clinical trials to ensure that they are conducted in accordancewith the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed appropriately.

- Contribute to and/or lead the creation of study-level documents, including protocol development, preparation ofclinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updatesand submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable).

- Under guidance of Clinical Development Lead, address regulatory/health authority queries and ensurecompliance with guidelines.

- Contribute to the development of the Clinical Development Plan, Integrated Evidence Plan and the clinical component of the TPP.

- Collaborate with cross-functional teams, including, but not limited to, clinical operations, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs.

- Develop protocol and clinically relevant training materials, share best practices and provide training to the broader clinical trial teams, investigator sites, CRO partners, etc.

- Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection.

- Contribute to aggregate reports, patient narrative reviews, attendance of pharmacovigilance monitoring meetings)

- Support regulatory activities, like preparation of meetings with regulatory agencies.

- Support preparation and (if applicable) participate in study level meetings, for example Investigator Meetings, Data Monitoring meetings, and others.

- Supports and guides the development of 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, andimplementation of data capture tools.

- Perform high quality clinical data review and identify clinical data insights through ongoing patient level reviewand trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities andresolution of scientific & medical issues throughout the study lifecycle.

- Work 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.

- Provide insights and facilitate data review process improvements, for example by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.

- Work effectively in a matrixed team within the clinical science organization. For Director level this includes providing guidance and mentorship to junior team members.

A Good Match:

- College degree in life sciences/healthcare/nursing. Advanced degree preferred

- 8+ years of industry experience

- Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3;ideally paired with experience in Oncology / Immuno-Oncology

- Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical companyor contract research organization (CRO), or comparable experience within academic research institutions.

- Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems andtools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in howto improve and accelerate processes, systems and tools and drive continuous improvement.

- Experience to work in a matrix, ability to influence without authority

- High flexibility and adaptive working style, ability to work on several tasks at the same time

- Ability to work effectively under high time pressure, while maintaining high quality standards

- Ability to effectively prioritize tasks, and implement accordingly

- High proficiency in English (written and spoken)

Your benefits:

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.

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 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.