Dermavant Hiring For Lead Clinical Research Associate at Morrisville, NC  Full Time

About Dermavant:

Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions. We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do, and this strong sense of purpose inspires us to bring the brightest people together to deliver the best products in dermatology.

It also brings great culture. In August 2021, the Los Angeles Business Journal named Dermavant one of the “2021 Best Places to Work in Los Angeles,” and Fortune named Dermavant one of the “100 Best Small Workplaces,” the company’s third recognition in a row by the magazine. For more information about Dermavant, check out our Glassdoor page or visit us on LinkedIn and Twitter.

With 150+ years of combined dermatology expertise from the Dermavant leadership team working towards our goal of transforming lives, the future at Dermavant is bright. We are excited for you to see what’s next!

Position:

The Lead Clinical Research Associate will support clinical trial management with a focus on Phase IV Interventional Studies. You will assist in trial set-up, execution, oversight, and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and ensure clinical inspection readiness through the lifecycle of the trials. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.

Responsibilities:

• Plans, leads, and manages study start-up activities e.g., creation and/or review of Laboratory Manual, Site Initiation Presentations, case report form (CRF), and various forms, study tracking and management documents, Investigator Meeting Planning
• Contributes to CRO selection, site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to act on any deviations from agreed plan
• Manages oversight of CRO, including project tracking of subject and site information, and helps prepare metrics and updates for management
• Ensures data quality including review of data metrics and listings, and protocol deviations
• Manages and files documents within electronic and/or paper Trial Master File
• Participates in the development and review of departmental SOPs and processes
• Overnight travel, both domestic and international, is required (approximately 25%)
• Reviews and manages monitoring visit reports
• May be assigned other projects and duties as required

Qualifications:

• At least 4+ years of clinical trial (phase II to IV) experience in the pharmaceutical or biotechnology industry
• BS or BA in a relevant scientific discipline
• Ability to multi-task and shift priorities quickly while working under tight deadlines
• Skilled in developing collaborative internal and external relationships
• Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials
• Strong computer experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)

What we look for in our people:

• Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
• Desire to work in a quickly changing and fast-paced growing business.
• Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
• Ability to overcome ambiguity and challenge the status quo.
• Manage multiple programs with competing and aggressive timelines – prioritize activities and work independently.
• Excellent written and oral communication skills. Experienced presenter of key messages to broad audiences including Senior Stakeholders.

As an equal opportunity employer, Dermavant is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.