Medical Director Rheumatology (m/w)Permanent role, office based in Germany or Belgium
+49 89 24 440 7117
Medical Director Rheumatology (m/w)
- 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(s) and drug candidate(s).
- With the Benefit Risk Team, ensure the study-related safety of the subjects in the clinical trials through appropriate safety signal detection and medical monitoring of studies on an ongoing basis – with or without independent data and safety monitoring boards.
- Establish and maintain credibility of the Global Therapeutic Area strategy while interacting with other internal departments and external experts for the assigned area(s) of responsibility.
- 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.
- Promote scientific innovation, in collaboration with New Medicines and Global Exploratory Development.
- Assume responsibility for correct and updated medical/scientific information for the respective therapeutic field and ensure its incorporation into the Clinical Development Plan (CDP).
- Assure medical/scientific integrity of clinical development programs and their deliverables (e.g. protocols, clinical study reports, etc.)
- Being the medical contact person with the investigators, the Med. Dir. is the frontline representative towards the medical community.
- Medical monitoring: Responsible for subject inclusion issues and subject management issues that require medical judgment.
- Reviewing the medical data, performing 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.
- Interaction with an independent Data Safety Monitoring Board may be needed.
- Ongoing review of selected data relevant for the safety of subjects, beyond reviewing of SAE information.
- Leading and contributing to the SAE reconciliation process between the clinical study and global drug safety databases. The Med. Dir. will also play a major role in the pre-analysis data evaluation meetings.
- 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 Missions and the Clinical Study Team(s) on medical/scientific issues related to the therapeutic field in question.
- Collaborate with the Clinical Program Directors and the program Medical Director on medical/scientific aspects of clinical development program.
- Active observation and adoption of relevant new scientific trends/tools in assigned therapeutic area and disease area(s).
- Speaking at conferences, symposia, and advisory board meetings.
- Develop and provide input towards the medical/scientific content of the Integrated Safety/Efficacy Summaries (ISS/ISE) and clinical overviews for assigned clinical development program submissions in close collaboration with Clinical Program Directors .
- Cooperate with Commercial, Medical Affairs and Market Access on medical/scientific marketing aspects and publications/presentations.
- Provide therapeutic expertise to Business Development by assisting with the medical/scientific evaluation of licensing-in compounds.
- Assist new scientific projects as a medical/scientific advisor to New Medicines, Global Exploratory Development.
- Evaluate potential new projects and provide input to draft Clinical Development Plan(s), as needed.
- Global travel required.
What is required:
- Medical Doctor with additional certification in Rheumatology
- Several years of experience in academia or other science-driven work environments substantiated by a relevant scope of publications, naming as IP (Investigation Product) (co)-inventor, or other suitable, publicly available tools for individual medico-scientific benchmarking.
- Profound experience in pharmaceutical industry, including all aspects of clinical development process is required.
- The Med. Dir. should be a respected individual who is considered, internally and externally, a medical/scientific expert (e.g. KOL) in the assigned disease area.
- Experience in writing and filing regulatory documents (including safety updates) is preferred.
- Expert knowledge (e.g., board certification) of assigned therapeutic area and disease area is preferred.
- Demonstrates 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.
- Expert knowledge of the therapeutic area.
- Readiness to work in a global matrix type environment.
- Coaching and mentoring skills.
- Results oriented.
- Team spirited.
- Scientific curiosity and ability to innovate combined with attention to timelines, results and added value.
- Readiness to build effective working relationships with colleagues at all levels in the organization.
- Capable to work without supervision. Can coach/mentor Associate Medical Director
- Can see underlying or hidden scientific/medical problems.
- Can manage uncertainty and risks.
- Ability to comprehend and interpret clinical data.
- Ability to work independently to solve complex problems on multiple concurrent projects.
- Understanding of complexities of global clinical development.
- Ability to detect medical inconsistencies within and between patients.
- Ability to manage conflict and achieve consensus in a team through complex and thorough deliberation.
- Regularly interacts with Senior Management on issues relating to several functional areas, often requiring negotiation and innovative ideas.