The TA Clinician MD also supports the Global Clinical Lead in the Clinical Development strategy and supports the organization of expert panels and advisory board meetings to provide input into clinical plans, study design or data analysis. The TA Clinician will also be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol.
In addition to study specific activities, the TA Clinician MD may provide product/program specific medical input for target product profile(s), due diligence activities on potential in-licensing opportunities and regulatory documents as appropriate (e.g. product labels, core data sheets, Investigator’s Brochures, Development Safety UpdateReports, Periodic Benefit-Risk EvaluationReports).
The Therapeutic Area (TA) Clinician, MD is accountable for the medical & scientific integrity of the study and the well-being of the patients enrolled for a particular TA. This role serves as the protocol owner and applies technical and clinical/medical excellence to ensure the design of cost-efficient clinical trials to meet the needs of internal and external customers.
S/he is responsible for effective medical/scientific oversight of studies (in partnership with TA Clinicians, Clinical Scientists and Clinical Operations team members) and supports appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). The TA Clinician MD safeguards compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues.
Provides medical input to develop study outline and/or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments in a Therapeutic Area.
Required: M.D. or equivalent medical qualification.
Preferred: Postgraduate training/certification /fellowship in a medical discipline or in drug development. Oncology or Hematology experience strongly preferred.
Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).