Associate Director, Clinical Development

Revance; Tennessee; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive compensation

Flexible PTO

Healthcare benefits

Job summary

Revance is seeking an Associate Director, Clinical Development to support strategy and execution of Phase 1-3 trials across therapeutic indications. You will collaborate with the VP of Clinical Development and Data Science to design studies, develop protocols, and prepare regulatory submissions for NDA/BLA.

The role entails authoring clinical documents, presenting at scientific meetings, interacting with CROs and KOLs, and guiding investigators.

Qualifications

• MD, DO, PhD, PharmD, or other recognized doctorate-level education required.
• Minimum 7–10 years of experience in design, execution and evaluation of clinical trials (phases 2–4).
• Experience with IND and (s)NDA/BLA submissions and regulatory interactions.

Responsibilities

• Develop scientific methods, design clinical studies, and implement protocols.
• Gather internal and external feedback on research programs and study results.
• Accountable for study protocols in collaboration with Biostatistics, Clinical Operations, Safety and Medical Affairs.
• Represent clinical research on trial teams and advance publications/presentations.
• Recruit, guide, and motivate clinical investigators and external partners/CROs.
• Support Data Monitoring Committees and Data Safety Monitoring Boards with presentations.
• Create and edit Clinical Study Reports, investigator brochures, and regulatory submissions.
• Ensure SOPs and GCPs are followed and report to leadership.

Skills

Excellent communication skills

Strong presentation skills

Cross-functional teamwork

Education

MD/DO/PhD/PharmD or equivalent

Job description

Job Summary

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. They will 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. They will contribute to the execution of Phase 1-3 clinical studies. They will author/contribute to clinical documents for regulatory submission and serve as internal author for presentations and publications. They will represent the company in regulatory meetings and scientific conferences, interact with external KOLs and internal stake holders, and serve as a critical internal scientific and clinical partner. They will work closely with internal clinical operations staff and contract research organizations (CROs) who are conducting studies.

Reports to: Vice President, Clinical Development and Data Science

Essential Duties and 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.

Required Experience

• 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. 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.

Required Education

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

Preferred Additional 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%

Company Summary

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. For more information about Revance, please visit us at www.revance.com.

What Revance invests in you

• 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!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a \"qualified individual with a disability\" in all aspects of the employment relationship. A \"qualified individual with a disability\" is \"an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.