Medical Director (m/f/d)*
Become part of a global Biotech founded by Scientifics and physicians that is constantly exploring the frontiers of science, rendering the highest scientific and ethical standards into solutions to the most acute health challenges affecting people nowadays.
In our offices across 3 countries, our 2500+ members are working on developing more than 17 therapeutical products. With a total flat hierarchy and focusing on keeping a healthy work and life balance, we harness the power of our immune systems to tackle cancer and infectious diseases. As a Medical Director on Clinical Trials you will play a crucial role in turning these novel technologies into safe and effective outcomes that will alleviate the ordeal of peoples affected by these diseases. Here you will have the opportunity to make scientific history.
Your main Responsibilities:
- Work in collaboration with clinical leads to develop clinical trial protocols, as well as assessing current protocols, identifying and proposing remedies to make sure they meet both our high scientific and ethical standards as well as current rules and regulations.
- Act as the lead medical monitor.
- Take part on the production of scientific documents, including crucial regulatory information such as investigator's brochures, briefing books and regulatory brochures, safety updates and submission dossiers. Review and write trial documents for CTR activities and publications.
- Be part of pharmacovigilance activities, by helping drafting aggregate reports, patient narratives, and attending pharmacovigilance monitoring meetings, among others.
- Help training clinical trial teams, preparing training materials and sharing best practices.
- Support regulatory activities and prepare meetings with regulatory agencies.
- Prepare and participate in study level meetings, e.g. Investigator Meetings.
- Take part of the development of data review strategy, to ensure that protocol-level deviations, eligibility criteria, study assessments and 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.
- Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution 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 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.
All these tasks must be carried on in close collaboration and alignment with clinical development lead. Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead.
What you bring:
- You have an advance degree in life sciences, healthcare, or clinically relevant degree. A medical degree is required.
- You have experience in medical monitoring for clinical trials.
- You are strongly familiar with Good Clinical Practice (GCP) and the process of drug development, ideally Phase 1-3. Experience in Oncology / Immuno-Oncology is a plus.
- You know how to set-up, organize and execute a global clinical studies in a pharmaceutical company, a contract research organization (CRO), or you have comparable experience within academic research institutions.
- You know about clinical data collection and reporting and have the ability to use tools for its analysis. Ideally you also have first experience in how to improve and accelerate processes.
- You are highly flexible, able to do multiple tasks and know how to prioritize among them.
- You can work under pressure while keeping high quality standards.
- Excellent English skills; German is a plus.
Benefits for you:
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
- ... and much more.
*We do 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!