Position Title: Medical (Sr.) Manager
Function: Medical Science, Clinical Development
Entity: Laekna Therapeutics
• Clinical development strategy and plan (including protocols) for all portfolio projects.
• Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring).
• Co-owners of clinical study delivery (with Stats and Clinical Operations).
• Analysis and interpretation of clinical study results in partnership with other functions.
• Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design.
• Liaise with PV for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting.
• Protocol development preparation for review by the Clinical Challenge and Protocol Review Committee.
• Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction.
• Be a TA clinical science expert and supporting China regulatory filing and registration.
• Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project.
• Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators.
Laekna Therapeutics is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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