Associate Director, Clinical Development

Job Summary

The Associate Director, Clinical Development will support the advancement of Revance therapeutics products and indications through the design and execution of Phase 1-3 clinical studies. This role will contribute to clinical program strategy, study design, protocol development, and regulatory submissions to support expanded therapeutic applications. Responsibilities also include developing clinical and scientific content for publications and presentations, participating in regulatory meetings and scientific conferences, engaging with external KOLs, and partnering closely with internal stakeholders, Clinical Operations, and CROs to support successful study execution.

Responsibilities/Essential Duties

• Develop scientific methods, design clinical studies, and develop 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 relevant sections of protocols, Clinical Study Reports, investigator brochures, IND/BLA submissions, and other clinical/regulatory/safety documents.
• Regularly report to clinical development and scientific leadership.
• Ensure study compliance by understanding and applying all relevant SOPs and GCPs.
• Present technical information to internal teams; represent Revance externally through publications and presentations at scientific meetings and congresses.
• Participate in long-range strategic product planning for current and future products.

Basic Qualifications

• Advanced Degree & 7-10 years' directly related experience.

Preferred Qualifications

• MD, DO, PhD, PharmD, or other recognized doctorate-level education.
• 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. This will include KOLs, key research centers, patient advocacy groups, and a variety of patient care organizations.
• Able to write clearly and succinctly in a variety of communication settings. Open, transparent, and succinct communication skills.
• Experience working with corporate/academic partners and contract research organizations.
• Excellent communication skills, both written and verbal.
• Effective team member with outstanding interpersonal skills.
• 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%.