Associate Director, Clinical Development

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

📋 Description

• Assist in the progression of Revance therapeutics products and indications by designing and executing Phase 1-3 clinical studies.

• Contribute to the strategy of clinical programs, design of studies, development of protocols, and submissions to regulatory bodies.

• Create clinical and scientific materials for publications and presentations.

• Participate in regulatory discussions and scientific conferences.

• Collaborate with external Key Opinion Leaders (KOLs).

• Work alongside internal stakeholders, Clinical Operations, and Contract Research Organizations (CROs) to ensure successful study execution.

• Formulate scientific methods and execute clinical protocols.

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

• Take responsibility for study protocols in partnership with Biometrics, Clinical Operations, Safety, and Medical Affairs teams.

• Act as a representative for clinical research by being a part of trial teams.

• Recruit, mentor, and inspire clinical investigators.

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

• Write sections of protocols, Clinical Study Reports, investigator brochures, IND/BLA submissions, and other related clinical, regulatory, and safety documents.

• Regularly report to clinical development and scientific leadership.

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

• Convey technical information internally and represent Revance externally through publications and at scientific gatherings.

• Engage in long-term strategic planning for product development.

⛳️ Requirements

• Advanced degree and 7-10 years of directly related experience.

• 7-10+ years of experience in the design, execution, and assessment of clinical trials, focusing on phases 2-4.

• Demonstrated success in recent IND and (s)NDA/BLA submissions.

• Experience overseeing physician-sponsored or company-sponsored clinical trials.

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

• Established network within Neurology or Physiatry, including KOLs, major research institutions, patient advocacy groups, and care organizations.

• Proficient in clear and concise writing across various communication contexts.

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

• Exceptional communication skills, both written and oral.

• Capability to devise project strategies and implement project specifics.

• Proven ability to operate successfully in a corporate setting while upholding the highest ethical, regulatory, and scientific standards.

• Well-developed problem-solving skills.

• Ability to learn and communicate clinical and non-clinical technical information effectively.

• Strong presentation and instructional abilities.

• Capacity to work autonomously and within cross-functional teams.

• Strong organizational and time-management skills, capable of handling multiple complex projects.

• Proficient in data analysis.

• Willingness to travel up to 30%.

🏝️ Benefits

• Competitive compensation package including base salary and annual performance bonus.

• Flexible paid time off, holidays, and parental leave.

• Comprehensive healthcare benefits.

• HSA matching.

• 401k matching.

• Employer-covered life and disability insurance.

• Pet insurance available.

• Wellness discounts and much more!