Associate Director, IT Development & Regulatory Business Partner

Company: Initial Therapeutics, Inc.
Location: San Diego
Posted on: March 29, 2025

Job Description:

Job Title:Associate Director, IT Development & Regulatory Business PartnerLocation:HybridPosition type:Full timeFLSA:ExemptDepartment:IT R&DID:9180-2025-7Strive to Bring a Profound Difference to our PatientsAt Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.The OpportunityThe Associate Director, IT Development & Regulatory Business Partner will play a pivotal role in supporting Avidity's R&D functions by driving a robust digital strategy that is essential for the success of our R&D pipeline and operational excellence. Working with the Clinical Development and Regulatory Affairs Leadership team(s), you will create and maintain Clinical and Regulatory Affairs IS strategy and roadmap, aligned to business goals and identify opportunities where IS can bring about efficiencies, embed quality, and drive business innovation. As a business partner, you will lead delivery of operational efficiencies, ensure effective adoption of new solutions and promote best-in-class customer experience.What You Will Contribute

• Develop a detailed understanding of Clinical Development business processes to serve as subject matter expert on behalf of business stakeholders as new technology solutions and enhancements are implemented.
• Develop close working relationships with the Clinical Development teams through effective project engagement and consistent delivery of business expectations.
• Support effective adoption of new systems by working closely with business partners to create high-quality training materials and user support.
• Gain a detailed knowledge of Clinical Development business processes through shadowing, process review, and collaboration.
• Ensure the strategic use of technology capabilities and business process improvements to drive business growth.
• Lead the prioritization of the Clinical systems portfolio and represent the portfolio to stakeholders.
• Maintain pulse on industry technology trends/initiatives and communicate to appropriate business and IS staff.
• Apply knowledge of the pharmaceutical industry, maintain awareness of the competitive environment, and consistently exhibit knowledge seeking and sharing best practices in all facets of responsibilities.What We Seek
  • A Bachelor's Degree or equivalent experience, with a strong understanding of how digital strategies can transform business operations. 6+ years experience in leadership capacity within a regulated setting; or equivalent.
  • Proven track record as a relationship manager/consultant within a global organization providing strategic planning, business process management, technical direction, customer engagement, and communication plans. This includes leading business process re-engineering initiatives and leading the selection, deployment, and adoption of new technologies.
  • Proven success handling a portfolio of projects and services across multiple business functions in areas such as: clinical trial management, trial master file, risk-based monitoring, regulatory information management systems, quality management systems, adverse event reporting, biometrics, data analytics and document management.
  • Demonstrated success driving organizational change management in the adoption of new capabilities business processes.
  • Excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.What We Will Provide To You
    • The base salary range for this role is $185,250 to $204,750. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
    • Avidity offers competitive compensation and benefits, which include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
    • A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.Avidity Biosciences10578 Science Center Dr. Suite 125San Diego, CA 92121O: 858-401-7900F: 858-401-7901
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Keywords: Initial Therapeutics, Inc., San Diego , Associate Director, IT Development & Regulatory Business Partner, Executive , San Diego, California