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Medical Director

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  64441

Help us transform patients’ lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

Job Summary  

  • A Medical Director (MD) 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.
  • Collaborate with relevant UCB departments in order to follow-up the operational implementation of assigned trials or clinical development programs.
  • Establish and maintain credibility of the Global Clinical Development and Medical Affairs 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.
  • Translation of Medico-scientific innovation for corporate projects
  • Promote scientific innovation, in collaboration with Research and Experimental Medicine.

 

 

 

 

Major Accountabilities

  • 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 UCB 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: Analyze 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.
  • Active observation and adoption of relevant new scientific trends/tools in assigned therapeutic area and disease area.
  • 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 UCB with the internal and external community including various regulatory and governmental agencies.
  • Represent UCB by speaking at conferences, symposia, and meetings.
  • 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.
  • Cooperate with Marketing 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.
  • Lead new scientific projects as a medical/scientific advisor.
  • Evaluate potential new projects and provide input to draft Clinical Development Plans, as needed.
  • Review relevant scientific literature related to disease area.
  • Such other responsibilities and projects that the Company may assign.

 

Education and Qualification

  • Medical Degree

 

Competencies

  • Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent UCB internationally at meetings and congresses. Ideally, the MD should strive to be seen as a KOL or equivalent and to provide leadership and mentoring for people in UCB.  Written documents do not require further editing.
  • Basic knowledge of GCP
  • Excellent knowledge of the therapeutic area
  • Readiness to work in a global matrix type environment
  • Coaching and mentoring skills
  • Results oriented
  • Team spirit
  • 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 Directors
  • Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
  • Can see underlying or hidden scientific/medical problems.
  • Can manage uncertainty.
  • 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 or Executive levels on issues relating to several functional areas, often requiring negotiation and innovative ideas.


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