Associate Director, IT Business Partner - GxP Systems

The Company:
With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role: 

Nuvalent is seeking a seasoned Associate Director, IT Business Partner – GxP Systems.    This individual is familiar with leading a skilled IT team in implementing GxP IT solutions across the Clinical, Quality and Regulatory pharmaceutical space.  In this hands-on role, you will work closely with the Quality, Regulatory, and Clinical teams to help identify, design, and support critical business applications at Nuvalent.  This position reports to the Vice President of Information Technology.

Responsibilities:

• Lead and manage the support of key IT applications for the GXP organization.
• Lead project lifecycle activities such as planning, requirement gathering, design, build, validation, implementation and post-implementation support of GxP applications.
• Act as the IT liaison between internal business partners and outside vendors.
• Ensure all GxP systems maintain compliance with 21 CFR Part 11 regulations by managing product release and update cycles.
• Works with Clinical, Quality, Regulatory, and IT teams to maintain GxP system and CSV SOPs.
• Responsible for all change control activities of the GxP platforms.
• Lead business stakeholders through the Business Analysis life cycle and Computer System Validation
• Identify and promote new platform features and drive adoption.
• Provide technical expertise on integration technologies such as APIs, Web Services and ETL to simplify our system landscape and enhance user experience.
• Ensure all service SLAs are met by developing strong partnerships with service providers.

Competencies Include: 

• Excellent problem solving, communication, and organization skills are required.
• Flexibility with changing priorities, ability to work well under pressure, and take on unfamiliar tasks is required.
• Ability to saliently communicate with end users is required.
• Ability to strategically plan, organize, and manage multiple projects simultaneously is required. 
• Strong work ethic with an ability to meet deadlines is required. 
• Some off-hours or evening work may be required.   

Qualifications:

• Bachelor or advanced degree in information technology/business solutions or equivalent work experience is required.
• Minimum of 10 years of pharmaceutical/biotech industry experience leading technology driven transformations.
• A minimum of three (3) years hands-on technical Veeva experience required. Ideal candidates will have implemented various modules within Veeva and have experience with Vault QMS, Vault QualityDocs, Vault Training, and RIM Suite.
• Experience in development of Interfaces/Integration between Veeva platform and other systems.
• Experience with SDLC change control processes in a GxP environment.
• Experience with the implementation and management of cloud/SaaS systems in GxP environments.
• Prior experience in pharmaceutical/biotechnology industry and an understanding of clinical development and regulations (Good Clinical Practice, 21 CFR Part 11).
  • Skilled in business process mapping. Certification in Business Analysis (ex. PMI-PBA) desirable.
  • Experience in Project Management.
  • Demonstrated verbal and written communication skills.
  • Demonstrated analytical, problem-solving, and conceptual skills.
  • Strong teamwork and interpersonal skills.
  • Able to work effectively in a WFH environment using self-management principles.

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.c