Design clinical trials and provide sound statistical guidance on clinical development projects; provide sample size estimates for proposed studies; oversee and monitor CRO performance on implementation of SAP.
Lead market research activities to inform clinical & preclinical development decisions; identify and escalate key competitor data release and study timelines to inform internal development decision making.
Conduct regular field visits and territory reviews with CNEs to ensure that proper programs and messages are being utilized and commitments are followed through; provide regular written and verbal feedback following field visits that address and support business and career-development needs of the CNE.
Provide strategic counsel regarding matters affecting financial community's perception of Ionis' performance and/or strategies, including timing of key announcements as well as competitive positioning of company and competitive responses.
Understands key market trends and competitive environment to drive proactive strategies to maximize brand potential; ensures timely and efficient review of promotional materials and complies fully with all legal, regulatory, ethical and company guidelines.
Identify relevant and emergent commercial guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is implemented into development planning and execution; communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review.
Develop strategies for relationships with medical experts and regional and local medical societies (relevant areas may include neurology, cardiology and hematology); define and monitor performance metrics and maintain accountability for the region.