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Medical Director Rheumatology (m/f)

Workscope: Clinical Research ·  Consulting

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Medical Director Rheumatology (m/w)

Permanent role, office based in Germany or Belgium
Contact DOCS:
Alina Kryzhanovskaya
Theresienhöhe 28
80339 München
+49 89 24 440 7117

Our client:

Our client is a globally renowned pharmaceutical company with a fast-growing product portfolio and a highly innovative research & development approach. Due to expansion, our client is currently hiring a

Medical Director Rheumatology (m/w)

to ensure the medical & scientific coherence and quality of clinical development programs conducted in the assigned therapeutic area.

Key responsibilities:

  • 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.

What is offered:

Our client offers you the opportunity of joining an inspired, successful team and working in a highly diversified global environment. Sustainable growth, innovation and a well-filled product pipeline are part of our client’s success journey where you and your team will be constantly improving health and quality of life for a vast number of individuals.


Please submit your CV to alina.kryzhanovskaya@docsglobal.com. We are looking forward to getting to know you.
Not interested in a change just yet? Please get in touch with me for prospective project requirements and join our talent network to stay informed about new opportunities in the future!
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