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Medical Director

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  68663

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

 

 

 

To strengthen our Clinical Development Team, based in our RTP Office in Raleigh - Durham, NC, we are looking for a talented individual to fill the position of: Medical Director or Senior Medical Director.

 

As a Medical Director you will serve as 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 on the operational implementation of assigned trials or clinical development programs.
  • Establish and maintain credibility of Global Clinical Development 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’s 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 medical-scientific innovation for corporate projects

 

You will contribute by:

  • Assuming responsibility for correct and updated medical/scientific information for the respective therapeutic field and ensures its incorporation into the Clinical Development Plan (CDP).
  • Assuring 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.
  • Conducting or overseeing medical monitoring: Responsible for subject inclusion issues and subject management issues that require medical judgment.  The MD is responsible for 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.  If medical monitoring is transferred to the 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. 
  • Ensuring Data Quality: Provide medical input in the database cleaning strategy (e.g. Data Cleaning Plan) to ensure adequate and efficient data cleaning.
  • Providing review, input and/or finalizing 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.
  • Providing 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.
  • Collaborating with the Clinical Program Directors and the Clinical Research Physicians and Scientists on medical/scientific aspects of clinical development program.
  • Providing active observation and adoption of relevant new scientific trends/tools in assigned therapeutic area and disease area.
  • Establishing, developing, and maintaining contacts worldwide with key opinion leaders and experts of assigned therapeutic area and disease area.
  • Serving as global medical/scientific spokesperson for UCB with the internal and external community including various regulatory and governmental agencies.
  • Representing UCB by speaking at conferences, symposia, and meetings.
  • Developing and providing 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.
  • Cooperating with Marketing on medical/scientific marketing aspects and publications/presentations.
  • Providing therapeutic expertise to Business Development by assisting with the medical/scientific evaluation of licensing-in compounds.
  • Leading new scientific projects as a medical/scientific advisor.
  • Evaluating potential new projects and providing input to draft Clinical Development Plans, as needed.
  • Reviewing relevant scientific literature related to disease area.
  • Incorporating other responsibilities and projects that the Company may assign.

 

Interested? For this position you’ll need the following education, experience and skills:

Qualifications:

  • Medical Degree (M.D.), Epileptologist preferred; experience in epilepsy required.
  • Minimum of 5 years’ 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 medical-scientific benchmarking.
  • Should be a highly-respected individual who is considered, internally and externally, a medical/scientific expert (e.g. KOL) in the assigned disease area (epilepsy).
  • Experience in pharmaceutical industry, including all aspects of clinical development process as well as writing and filing regulatory documents (including safety updates).
  • Expert knowledge (e.g., board certification) of assigned therapeutic area and disease area (neurology/epilepsy).
  • Readiness to work in a global matrix type environment.
  • Coaching and mentoring skills. 
  • Capable to work without supervision and serve as a Program Physician for a development program.

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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