Clinical Research Study Assistant supporting neurology clinical research at WashU. Assisting in data management, document compliance, and coordinating study personnel interactions.
About the role
- Vice President of Global Drug Safety at Amicus Therapeutics focusing on rare metabolic diseases and ensuring safety compliance. Driving innovation and high standards in pharmacovigilance and risk management.
Responsibilities
- Lead the pharmacovigilance and drug safety strategy for investigational and marketed products• Establish and maintain a comprehensive safety surveillance system to detect, assess, and report adverse events• Ensure compliance with global regulatory requirements (FDA, EMA, etc.) and guidelines (ICH, GCP) related to clinical safety• Provide safety assessments for clinical development, risk management plans, and post-marketing surveillance• Serve as the primary contact for regulatory authorities on safety issues and risk management strategies• Support GVP audit and inspection preparedness• Build, mentor, and lead high-performing teams in drug safety• Foster a collaborative environment that encourages innovative thinking and best practices• Partner with senior leadership to drive organizational growth and support company-wide strategic initiatives• Represent the company at key scientific, regulatory, and industry events to enhance external visibility and partnerships• Ensure safety activities are conducted in full compliance with local and international regulations• Collaborate with regulatory affairs on submissions, safety reports, and labeling for both investigational and commercial products• Maintain up-to-date knowledge of regulatory changes, industry trends, and scientific advancements affecting drug safety and clinical development• Provide expert clinical and safety risk assessments to support product development, regulatory filings, and commercial activities• Implement risk mitigation strategies for safety concerns that arise during clinical trials or post-approval• Critical leadership role in company governance forums related to safety, labeling, and clinical development strategy• Work closely with internal stakeholders to make informed, data-driven decisions on the progression of clinical programs• Support business development teams by providing safety expertise during the evaluation of potential in-licensing, co-development, or acquisition opportunities• Conduct in-depth due diligence on new assets, including assessing safety profiles, and evaluating regulatory pathways• Collaborate with internal teams and external partners to identify potential risks and opportunities associated with new assets
Requirements
- MD (or equivalent) in a related scientific or clinical discipline• 15+ years of experience in clinical development and drug safety within the biopharmaceutical industry• Experience with both small molecule and biologics development• Expertise in rare diseases (preferred) or another specialized therapeutic area• Global experience working across different regulatory regions (e.g., North America, Europe, Asia)• Deep understanding of global regulatory requirements and safety standards (e.g., FDA, EMA, ICH)• Experience managing cross-functional teams and external partnerships, including CROs and key opinion leaders• Strong leadership, communication, and decision-making skills with the ability to navigate complex, fast-paced environments• Strategic thinker with the ability to drive clinical innovation and foster a culture of excellence• Demonstrated alignment with Amicus Mission Focus Behaviors• Passion for rare disease and patient focused• Leadership & People Management• Strategic Thinking• Innovation & Problem Solving• Regulatory & Compliance Expertise• Effective Communication• Collaboration & Cross-functional Partnership
Benefits
- We respect and celebrate the diversity of our people, their backgrounds and experiences• Equal Opportunity Employer providing opportunities for all• Commitment to innovation, excellence, and fostering a collaborative environment
Job title
Job type
Experience level
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Degree requirement
Tech skills
Location requirements
Seeking an Advanced Practice Provider for part - time clinical research role at SRI. Flexible hours supporting studies in Plymouth, MI with potential for growth into longer - term positions.
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