(Senior-) Director, Clinical Science (m/w/d)

Mainz, Germany; London, United Kingdom; Munich, Germany   |   full time   |   Job ID: 8980 

Responsibilities

• In collaboration with the Clinical Development Lead,  develop the design of clinical trials to evaluate the safety and efficacy of investigational drug. This includes developing the study protocol, identifying patient populations, and selecting study endpoints.
• Support the Clinical Development Lead in the medical oversight  of clinical trials to ensure that they are conducted in accordance with 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 of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and 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 ensure compliance 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.
• Build and foster relationships with PIs and Key Opinion Leaders (KOLs) in relevant therapeutic areas.
• Develop training materials to support the understanding of the clinical trial protocol and/or disease indication.  Provide training to study team members, CRO staff, investigator staff, etc.
• Present at key meetings (e.g. SIVs, investigator meetings, IDMC meetings, 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, and implementation of data capture tools.
• Oversee the medical data review and analysis of clinical trial data across a platform/indication/asset to evaluate the safety and efficacy of investigational drugs. This includes working with biostatisticians to develop analysis plans, reviewing study data, and interpreting study results. Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation.
• Provide insights to 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.
• Line management of clinical science personnel inclusive of development, coaching, performance evaluations, etc.

Qualifications

• College degree in life sciences/healthcare/nursing.  Advanced degree preferred
• 12+ years of industry experience
• Prior experience managing a team
• 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 company or contract research organization (CRO), or comparable experience within academic research institution.
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in how to 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:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account  
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket 
• Your life phases: Employer-funded pension | Childcare 

Apply now - We look forward to your application!

Apply to our Mainz, Germany; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 8980 (please always specify if you have any questions)   

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.