Associate Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in research initiatives aimed at broadening the scope of Revance therapeutic products and their indications.

• Aid in the development of program strategies and the design of clinical studies.

• Create and update study protocols to obtain regulatory approval for therapeutic uses beyond cervical dystonia.

• Play a role in the implementation of Phase 1-3 clinical trials.

• Write or contribute to clinical documents for regulatory submissions, presentations, and publications.

• Represent Revance at regulatory meetings and scientific conferences.

• Collaborate with external Key Opinion Leaders (KOLs) and internal stakeholders as a scientific and clinical collaborator.

• Partner with clinical operations personnel and Contract Research Organizations (CROs) conducting studies.

• Formulate scientific methodologies and execute clinical protocols.

• Collect feedback from internal and external sources on clinical research programs.

• Work together with Biometrics, Clinical Operations, Safety, and Medical Affairs teams on study protocols.

• Recruit, mentor, and inspire clinical investigators.

• Provide support to Data Monitoring Committees and Data Safety Monitoring Boards with presentations.

• Draft protocols, Clinical Study Reports, investigator brochures, IND/BLA submissions, and other clinical, regulatory, and safety documents.

• Regularly report to clinical development and scientific leadership.

• Ensure compliance with applicable Standard Operating Procedures (SOPs) and Good Clinical Practices (GCPs) during studies.

• Deliver technical information both internally and externally through publications and scientific meetings.

• Engage in long-term strategic product planning.

⛳️ Requirements

• A minimum of seven to ten years of experience in the design, execution, and evaluation of clinical trials, specifically phases 2-4.

• A recent history of successful IND and (s)NDA/BLA submissions.

• Responsibility for overseeing physician-sponsored or company-sponsored clinical trials.

• Comprehensive understanding of pharmaceutical regulatory requirements and their implications for the development of clinical trials and NDA/BLA submissions.

• An established network within Neurology or Physiatry, including KOLs, key research centers, patient advocacy groups, and patient care organizations.

• Experience collaborating with corporate or academic partners and contract research organizations.

• MD, DO, PhD, PharmD, or another recognized doctorate-level qualification.

• Willingness to travel up to 30% of the time.

🏝️ Benefits

• Competitive compensation package, which includes a base salary and an annual performance bonus.

• Flexible Paid Time Off (PTO) policy (12 days' PTO), along with holidays and parental leave.

• Comprehensive healthcare benefits.

• Health Savings Account (HSA) matching.

• 401k matching program.

• Employer-covered life and disability insurance.

• Pet insurance options.

• Discounts on wellness programs.