Medical Director
Raleigh, NC 
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Posted 4 days ago
Job Description
JOB DESCRIPTION

Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?


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 the project teams. This candiate may be located in any of our three major hubs: US - Raleigh, NC, Monheim, Germany or Slough, United Kingdom. We offer a hybrid working model.

You like to work in an environment where you can:

  • 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 the 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 Medico-scientific innovation for corporate projects
  • 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.
  • 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 Strategic Partnership CRO, the MD is responsible for the oversight of activities.

You will contribute by:

  • Interacting with an independent Data and Safety Review Board.
  • Reviewing 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.
  • Playing a major role in pre-analysis meetings.
  • Providing medical input in the database cleaning strategy (e.g. Data Cleaning Plan) to ensure adequate and efficient data cleaning.
  • Providing 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.
  • Analyzing study results and reporting findings in the CSR and recommending new paths based on the lessons learned.
  • 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.
  • Observing and adopting 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 and 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 provide input to draft Clinical Development Plans, as needed.
  • Reviewing relevant scientific literature related to disease area.

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

Minimum Qualifications:

  • A MD must have a 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 medico-scientific benchmarking.
  • The MD should be a highly respected individual who is considered, internally and externally, a medical/scientific expert (e.g. KOL) in the assigned disease area.
  • Experience in pharmaceutical industry, including all aspects of clinical development process as well as writing and filing regulatory documents (including safety updates) is preferred.
  • Expert knowledge (e.g., board certification) of assigned therapeutic area and disease area is required.
  • 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, to include excellent knowledge of the therapeutic area.
  • 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.

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease?". We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website .

Where permitted, applicants for employment in the United States must have received or be willing to receive a full COVID-19 vaccination by the date of hire; or, alternatively, agree to be subject to weekly COVID-19 testing, subject to religious and medical exemptions and in accordance with applicable law.

UCB is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protect by law.


UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
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