Date: Aug 16, 2019
Location: Braine L'alleud, Walloon Brabant, BE
Programme Physician - Neurology
Board certified neurologist providing global strategic medical input to the tau development programme. Accountable to the Development Team Leader for:
* Detailed knowledge of the disease(s) under study, understanding the associated unmet medical need, science, medicine, emerging data and current treatment options
* Provides specialist neurology input to the design of the overall clinical development programme supporting the required indication in the NDA/BLA/MAA/JNDA, including:
o Patients populations
o Study design, objectives, endpoints, analysis plans
o Risk benefit profile
o Authorship of clinical expert report and input to ISS and ISE
* Maintains a deep knowledge of the safety, efficacy and clinical pharmacology of the compound under development
* Represents the frontline representative of UCB towards the medical community, serving as global medical/scientific spokesperson for UCB with the internal and external community
* Cooperates with Marketing on medical/scientific marketing aspects and publications/presentations.
* Cooperates with Business Development to evaluate in- and out-licensing opportunities
* Participates to new scientific projects as a medical/scientific advisor.
* Member of PST or Development team, CRST or Clinical Team at Mission Level, SSDT, submission team and a voting member of the BRT.
* Provide medical input into TPVP
* Provide medical input into CDP and other parts of IEP
* Review study concepts for alignment with CDP
* Provide input to country selection strategy
* Provide medical input into PIP, PSP
* Participate at UCB governance meetings and clinical Advisory Board meetings
* Provide input in partnering activities
* Consult with medical experts for assigned programs (KOLs, HCPs), analyzing, reviewing and interpreting the information provided by external medical experts
* Provide information on adequate medical resources required for
clinical program incl. submissions
* A Program Physician can also act in the role of a Study Physician in parallel, if appropriate.
* Medical Input into Regulatory Strategy & HA Interactions
o Provide medical input into briefing packages for HA
o Answering medical Qs by HAs
o Medical expert at meetings with Regulatory authorities
o Provide medical input into CCDS and support Label negotiations with Regulatory authorities
o Provide input into Risk Management Plan
o Support audits / inspections
* Review & Approval of Clinical Documents, including:
o Investigators´ Brochure
o Clinical Overview
o Summary Clinical Efficacy
o Summary Clinical Safety
EDUCATION & QUALIFICATION
Ph.D or Medical Degree (M.D)
A Programme Physician Neurology must have a minimum of 3 years' experience in academia or other science-driven work environments substantiated by a relevant scope of publications. The Programme Physician Neurology 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 Programme Physician Neurology should strive to be seen as a KOL or equivalent and to provide leadership and mentoring for people in UCB.
* 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.
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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