Associate Director, Clinical Development

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 12%

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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 research activities leading to expansion of Revance therapeutic products and indications. • Assist in establishing program strategies and designing clinical studies. • Develop and revise study protocols to secure regulatory approval for therapeutic applications beyond cervical dystonia. • Contribute to execution of Phase 1-3 clinical studies. • Author or contribute to clinical documents for regulatory submissions, presentations, and publications. • Represent Revance in regulatory meetings and scientific conferences. • Interact with external KOLs and internal stakeholders as a scientific and clinical partner. • Work with clinical operations staff and CROs conducting studies. • Develop scientific methods and implement clinical protocols. • Gather internal and external feedback on clinical research programs. • Collaborate with Biometrics, Clinical Operations, Safety, and Medical Affairs groups on study protocols. • Recruit, guide, and motivate clinical investigators. • Support Data Monitoring Committees and Data Safety Monitoring Boards with presentations. • Author protocols, Clinical Study Reports, investigator brochures, IND/BLA submissions, and other clinical, regulatory, and safety documents. • Report regularly to clinical development and scientific leadership. • Ensure study compliance with relevant SOPs and GCPs. • Present technical information internally and externally through publications and scientific meetings. • Participate in long-range strategic product planning.

🎯 Requirements

• Minimum seven to ten years' experience in the design, execution and evaluation of clinical trials, 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. • Experience working with corporate/academic partners and contract research organizations. • MD, DO, PhD, PharmD, or other recognized doctorate-level education. • Ability to travel up to 30%.

🏖️ Benefits

• Competitive Compensation including base salary and annual performance bonus. • Flexible PTO (12 days' PTO), holidays, and parental leave. • Generous healthcare benefits • HSA match • 401k match • Employer paid life and disability insurance • Pet insurance • Wellness discounts