Associate Director, Clinical Development

Reporting to the Vice President of Clinical Development and Data Science, the Associate Director, Clinical Development will support research activities leading to the expansion of Revance therapeutic products and indications.

About the role

Assist in establishing program strategies, help design clinical studies, and develop/revise study protocols to secure regulatory approval for therapeutic applications beyond the currently approved cervical dystonia indication. Contribute to the execution of Phase 1-3 clinical studies. Author and contribute to clinical documents for regulatory submission and serve as internal author for presentations and publications. Represent the company in regulatory meetings and scientific conferences, interact with external KOLs and internal stakeholders, and serve as a critical internal scientific and clinical partner. Work closely with internal clinical operations staff and contract research organizations (CROs) who are conducting studies.

Responsibilities

• 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 the 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, presentations at scientific meetings and congresses.
• Participate in long-range strategic product planning for current and future products.

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 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.

Qualifications

• MD, DO, PhD, PharmD, or other recognized doctorate-level education.

Preferred Skills

• Excellent communication skills, both written and oral.
• 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%.

About the company

Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company’s vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance’s award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists.

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, and much more.