Acts as medical expert and leader in interactions with external stakeholders
Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape
Designs and develops more efficient and innovative, yet robust Phase 2/3 programs
Works closely with discovery teams to provide input on the next generation of targets in the field
Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance
Plans and executes publication and clinical communication strategy in coordination with Publications team
Develops written responses to regulatory agency questions and regulatory submission documents
Requirements
A minimum of an advanced degree in medicine (i.e., M.D. or D.O. or equivalent)
Clinical training in Endocrinology, Cardiology, Nephrology, Internal Medicine (board certified or eligible or equivalent) is strongly preferred
A minimum of 3-4 years of industry experience in early or late development
Past experience in leading clinical trials including: protocol design, managing study start-up, directing and guiding study team execution, data cleaning, medical monitoring/review, database locks
Experience with regulatory filings and interactions with health authorities preferred
Benefits
health and wellness programs
fitness centers
equity awards
annual bonuses
paid time off
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