Global Safety Director, Obesity – US, Remote
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Location: US-based, remote. The Global Safety Director for Obesity is responsible for the safety strategy, direction, and prioritization of pharmacovigilance activities for assigned products, ensuring the overall safety profile and regulatory deliverables. You will lead the Safety Analysis Team (SAT), Global Safety Team (GST), and serve as a core member of the Executive Safety Committee, working with cross-functional partners to bring therapies to market. This role requires leadership in safety signal validation, risk management, and regulatory filings. Responsibilities
Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Author /review and strategize safety sections of new drug applications and associated documents and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness Domestic and International travel up to 10% Qualifications
Required:
Doctorate degree and 4 years Safety experience OR:
Master’s degree and 7 years Safety experience OR:
Bachelor’s degree and 9 years Safety experience Preferred:
Product safety in the bio/pharmaceutical industry or regulatory agency Preferred:
Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training Preferred:
Experience with marketed product safety; risk management Preferred:
Experience with phase 1-3 clinical trials safety assessments and analyses Preferred:
Drug Submission experience (preferably multiple new drug submission experience) and regulatory interactions Preferred:
Leadership experience of the safety profile of products assigned with cross-functional team members Skills
Preferred:
Product safety in the bio/pharmaceutical industry or regulatory agency Preferred:
Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training Preferred:
Experience with marketed product safety; risk management Preferred:
Experience with phase 1-3 clinical trials safety assessments and analyses Preferred:
Drug Submission experience (multiple new drug submissions) and regulatory interactions Preferred:
Leadership experience of the safety profile of products assigned with cross-functional team members
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Location: US-based, remote. The Global Safety Director for Obesity is responsible for the safety strategy, direction, and prioritization of pharmacovigilance activities for assigned products, ensuring the overall safety profile and regulatory deliverables. You will lead the Safety Analysis Team (SAT), Global Safety Team (GST), and serve as a core member of the Executive Safety Committee, working with cross-functional partners to bring therapies to market. This role requires leadership in safety signal validation, risk management, and regulatory filings. Responsibilities
Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Author /review and strategize safety sections of new drug applications and associated documents and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness Domestic and International travel up to 10% Qualifications
Required:
Doctorate degree and 4 years Safety experience OR:
Master’s degree and 7 years Safety experience OR:
Bachelor’s degree and 9 years Safety experience Preferred:
Product safety in the bio/pharmaceutical industry or regulatory agency Preferred:
Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training Preferred:
Experience with marketed product safety; risk management Preferred:
Experience with phase 1-3 clinical trials safety assessments and analyses Preferred:
Drug Submission experience (preferably multiple new drug submission experience) and regulatory interactions Preferred:
Leadership experience of the safety profile of products assigned with cross-functional team members Skills
Preferred:
Product safety in the bio/pharmaceutical industry or regulatory agency Preferred:
Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training Preferred:
Experience with marketed product safety; risk management Preferred:
Experience with phase 1-3 clinical trials safety assessments and analyses Preferred:
Drug Submission experience (multiple new drug submissions) and regulatory interactions Preferred:
Leadership experience of the safety profile of products assigned with cross-functional team members
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