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Clinical Development Physician - Immunology

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  65986

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?

 

Our challenge. Your impact.

 

We aspire to be the patient-preferred global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.

 

At the earliest date possible we search for a Raleigh, NC based: Clinical Development Physician TA Immunology  who can support our Global Clinical Development team.

 

Scope of the role

A Medical Director/Clinical Development Physician 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.
  • 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

 

 

Your responsibilities in this role include

  • 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.
  • 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.
  • 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.
  • Evaluate potential new projects and provide input to draft Clinical Development Plans, as needed.

 

Education and Qualification

  • Medical qualification (MD) required
  • Min 5 years experience in pharmaceutical industry in clinical development including knowledge of GCP
  • Board certification or other relevant higher medical and academic qualification preferred
  • Clinical Development Experience with Immunology, ideally within Lupus
  • 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.
  • Strong team player with ability to work in global diverse matrix teams and to build effective working relationships at all levels in the organization
  • Scientific curiosity and ability to innovate combined with attention to timelines, results and added value

 

Have we made you curious?

Then we look forward to receiving your online application (please only use our online application tool) for this position stating your earliest availability or actual notice period as well as salary expectations. We thank you for your interest in UCB and look forward to get in touch with you! UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7500 people in approximately 40 countries, we generated revenue of EUR 4.6 billion in 2018.

Do you want to find out more about us then visit our website: www.ucb.com

 

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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