Associate Director, QRMC Systems

About Edgewise Therapeutics

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position

Edgewise Therapeutics is seeking an Associate Director of Quality, Regulatory, Medical, and Clinical (QRMC) Systems to join our I.T./I.S. team. This position will be responsible for the management support and development of the Veeva Vault product stack and other applications within Edgewise Therapeutics. This is a full-time position reporting to the VP, Head of IT/IS and is either to be based in Boulder, Remote or Hybrid.

Essential Job Duties and Functions

• Support and IT leadership of the entire Veeva Vault product stack including, but not limited to:
  • Quality - QMS, QDocs, Learning etc.
  • Medical – MedComms, PromoMats
  • Regulatory – RIM Submissions and Archive
  • Clinical – eTMF, CTMS, EDC etc.
• Support for the quality, medical, regulatory and clinical teams in the advance of use of technology to meet departmental and corporate goals.
• Subject matter expert in quality, medical, regulatory and clinical systems for the company globally.
• Owns the business systems roadmap for the quality, medical, regulatory and clinical areas. Collaborate with all functional areas to understand requirements and optimize processes.
• Participates in development, implementation, and maintenance of systems including, but not limited to:
  • New systems/applications implementations
  • Configuration changes and updates
  • System Planning – both short and long range
  • Tracking and evaluation of system validation
  • System Troubleshooting and guidance
• Collaborates with I.T. and Info Security teams to ensure that software, hardware, and cloud solutions provide the highest levels of security.
• Maintains a broad knowledge of state-of-the-art technology, equipment and systems.
• Manage service contracts and consultants related to systems coverage. Work with departments to optimize licensing agreements.
• Implement other information systems projects as they arise and perform other duties as assigned.
• Experience working closely with team responsible for Veeva CRM to maximize Commercial opportunities.

Required Education, Experience and Skills

• Bachelor’s degree in Computer Science/Information Technology or equivalent experience.
• Minimum of 10 years experience in pharmaceutical/validated quality, regulatory and clinical functional areas.
• Veeva Vault Platform Certified Administrator
• Trained and experienced in Computer Systems Validation
• Demonstrated ability to work independently or as a team member, self-starter with excellent communication skills.
• Must have demonstrated effectiveness as a hands-on, service and results oriented person who is willing and able to work on a wide range of activities.
• Ability to influence up, down and across the Organization
• The successful candidate must have excellent inter-personal, analytical, and communication capabilities and strong diagnostic and technical resolution skills. He/she must be service-oriented and capable of developing strong working relationships with others, regardless of level.

Working Conditions and Physical Requirements

• Occasional evening and weekend work will be required.
• Remote, Boulder based or Hybrid options all possible

Salary range: $150,000 - $190,000, title and salary commensurate with experience

Our Benefits

We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.