Medical Director Rheumatology (m/f)

Workscope: Clinical Research ·  Consulting

This job ad is out of date. Find related Jobs here.


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 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!
While applying for the job please refer to jobvector

About DOCS International Germany GmbH

DOCS International ist eine internationale Staffing Company für die Healthcare- Industrie. Hier bieten wir für unsere Kunden - namhafte Pharmaunternehmen, Biotechnologieunternehmen und CRO's - internationale Dienstleistungen an. Diese umfassen zum einen die Vermittlung von Fach- und Führungskräften an unsere Kunden, zum anderen die Rekrutierung eigner DOCS...

More about DOCS International Germany GmbH

Related jobs

Get jobs on a daily basis for free