Posted On: December 16th, 2017 Job Type: Pipeline Jobs Job Location:
1)Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications 2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates if applicable 4)May be the Program Manager of other associates (e.g.., CTH, CSE). 5) May act as study medical monitor 6) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety 7) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH 8) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards 9) May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed 10) Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support. Minimum Requirements Excellent negotiation and conflict resolution skills
Apply For This Job