Executive Medical Director/SERM Head driving clinical safety and pharmacovigilance strategy for Oncology. Leading global teams to ensure highest standards of patient safety with focus on regulatory compliance.
About the role
- 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
Job title
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Experience level
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Degree requirement
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