Associate Director, Clinical Development

🔥 2 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Revance

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

☁️ SaaS

📋 Compliance

🤝 B2B

💰 $100M Post-IPO Equity - Revance Therapeutics on 2024-03

SaaS • Compliance • B2B

Revance is the company name provided, but the supplied information appears to describe accessiBe. accessiBe is an expert-driven, AI-powered web accessibility company that provides automated remediation (accessWidget), accessibility scanning and developer tools (accessScan, accessFlow), manual expert audits and user testing, file/PDF accessibility, litigation support and attorney consultation, training and white-label partner programs, and integrations with major CMS and e-commerce platforms. The company emphasizes WCAG/ADA/EAA compliance, continuous automated updates, SOC2-level security, and sells subscription plans for small businesses through enterprise customers.

📋 Description

• Support advancement of Revance therapeutics products and indications through design and execution of Phase 1-3 clinical studies. • Contribute to clinical program strategy, study design, protocol development, and regulatory submissions. • Develop clinical and scientific content for publications and presentations. • Participate in regulatory meetings and scientific conferences. • Engage with external KOLs. • Partner with internal stakeholders, Clinical Operations, and CROs to support successful study execution. • Develop scientific methods and implement clinical protocols. • Gather internal and external feedback on clinical research programs. • Be accountable for study protocols in collaboration with Biometrics, Clinical Operations, Safety, and Medical Affairs groups. • Represent clinical research through membership on trial teams. • Recruit, guide, and motivate clinical investigators. • Support Data Monitoring Committees and Data Safety Monitoring Boards with presentations. • Author sections of protocols, Clinical Study Reports, investigator brochures, IND/BLA submissions, and other clinical/regulatory/safety documents. • Report regularly to clinical development and scientific leadership. • Ensure study compliance with relevant SOPs and GCPs. • Present technical information internally and represent Revance externally through publications and scientific meetings. • Participate in long-range strategic product planning.

🎯 Requirements

• Advanced Degree & 7-10 years’ directly related experience. • 7-10+ years’ experience in the design, execution, and evaluation of clinical trails, with an emphasis on phases 2-4. • Recent track record of successful IND and (s)NDA/BLA submissions. • Responsibility for physician-sponsored or company-sponsored clinical trials. • In-depth understanding of pharmaceutical regulatory requirements and their impact on development of clinical trials and NDA/BLA submissions. • An active network within Neurology or Physiatry, including KOLs, key research centers, patient advocacy groups, and patient care organizations. • Able to write clearly and succinctly in a variety of communication settings. • Experience working with corporate/academic partners and contract research organizations. • Excellent communication skills, both written and verbal. • Ability to develop project strategies and execute project details. • Demonstrated ability to function effectively in a corporate environment while maintaining the highest ethical, regulatory, and scientific standards. • Highly developed problem-solving capabilities. • Ability to effectively learn and convey clinical and non-clinical technical information. • Strong presentation and teaching skills. • Ability to work independently and with cross-functional teams. • Strong organizational and time-management skills, with the ability to manage multiple complex projects. • Strong data analysis capabilities. • Ability to travel up to 30%.

🏖️ Benefits

• Competitive Compensation including base salary and annual performance bonus. • Flexible PTO, holidays, and parental leave. • Generous healthcare benefits. • HSA match. • 401k match. • Employer paid life and disability insurance. • Pet insurance. • Wellness discounts and much more!

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