I am currently working with a Global Biopharma Company, with offices based internationally. We are looking for a Medical Doctor with extensive experience working with Immunology ideally with Lupus. This is a great opportunity for anyone looking to take the step into a company transforming the lives of people living with severe diseases.
Scope of the role
- A Medical Director/Clinical Development Physician is a recognized medical/scientific expert in the assigned disease area. As a member of the therapeutic area, the MD is responsible for providing medical/scientific input and expertise to:
- Ensure the medical/scientific coherence and quality of clinical development programs conducted in the assigned disease area.
- Contribute to the generation of the Clinical Development Plan(s) leading to successful registration and launch of NCEs/NBEs and additional approvals of new line extensions (indications or formulations) of registered compounds.
- Contribute to the design, conduct and interpretation of specific clinical trials, specifically their relevance for the target disease and drug candidate.
- Ensure the study-related safety of the subjects in the clinical trials through appropriate medical monitoring of studies on an ongoing basis – with or without independent data and safety monitoring boards.
- Contribute to the clinical section of documents including, but not limited to, the Investigator Brochure (IB), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview.
- Translation of Medico-scientific innovation for corporate projects
Your responsibilities in this role include
- Assume responsibility for correct and updated medical/scientific information for the respective therapeutic field and ensures its incorporation into the Clinical Development Plan (CDP).
- Assure medical/scientific integrity of clinical development programs and their deliverables (e.g. protocols, clinical trial reports, etc.)
- Being the medical contact person with the investigators, the MD is the frontline representative of the company towards the medical community.
- Medical monitoring: Responsible for subject inclusion issues and subject management issues that require medical judgment.
- The MD is responsible for reviewing the medical data; perform medical checks of that data when necessary and interacting with the investigator during the study.
- Medical monitoring includes on-site visits as appropriate to the complexity of the protocol. If medical monitoring is transferred to Strategic Partnership CRO, the MD is responsible for the oversight of activities. Interaction with an independent Data and Safety Review Board may be needed. Ongoing review of selected data relevant for the safety of subjects, beyond reviewing of SAE information. Contributing to the SAE reconciliation process between the clinical study and global drug safety databases. The MD will also play a major role in the pre-analysis meeting.
- Data Quality: Provide medical input in the database cleaning strategy (e.g. Data Cleaning Plan) to ensure adequate and efficient data cleaning.
- Provide review, input and/or finalize other critical study documents for the study such as the statistical analysis plan (SAP), informed consent forms (ICF), protocol deviations data management (PDDM), specification of protocol deviations (SPD), etc.
- Interpretation of results: Analyse the study results and report findings in the CSR and recommend new paths based on the lessons learned.
- Provide training and ongoing input to all members of the Clinical Team and the Clinical Study Team on medical/scientific issues related to the therapeutic field in question.
- Collaborate with the Clinical Program Directors and the Clinical Research Physicians and Scientists on medical/scientific aspects of clinical development program.
- Establish, develop, and maintain contacts worldwide with key opinion leaders and experts of assigned therapeutic area and disease area.
- Serve as global medical/scientific spokesperson for the company with the internal and external community including various regulatory and governmental agencies.
- Develop and provide input towards the medical/scientific content of the Integrated Safety/Efficacy Summaries and clinical overviews for assigned clinical development program in close collaboration with Clinical Program Directors and Clinical Research Physicians and Scientists.
- Evaluate potential new projects and provide input to draft Clinical Development Plans, as needed.
Education and Qualification
- Medical qualification (MD) required
- Min 5 years’ experience in pharmaceutical industry in clinical development including knowledge of GCP
- Board certification or other relevant higher medical and academic qualification preferred
- Clinical Development Experience with Immunology, ideally within Lupus
- Clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent the company
- internationally at meetings and congresses.
- Strong team player with ability to work in global diverse matrix teams and to build effective working relationships at all levels in the organization
- Scientific curiosity and ability to innovate combined with attention to timelines, results and added value
Please note this job Opportunity is available for a variety of offices, in Belgium, UK, and Germany
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to Amber Winstone at awinstone (@) barringtonjames (dot) com alongside a copy of your CV.