IT R&D Apps Manager
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
Accomplishes IT R&D Applications Manager objectives by managing staff; designing and monitoring the planning, configuration, and deployment of our Clinical Trials Management System (CTMS), Pharmacovigilance systems (Oracle Argus), Quality Management Systems and other associated systems in support of core R&D functions and processes. This resource will be the System Owner for above systems and will collaborate closely with Drug Safety, Clinical Science, Regulatory, other R&D departments, other IT resources and our SaaS vendors. The position will work closely with the R&D Teams and report directly to the Associate Director, IT & R&D Applications.
The IT R&D Applications Manager will be a valuable member of the IT R&D team to deliver the future-state requirements and current-state system improvements. In addition to supporting the IT R&D applications, the IT R&D Applications Manager will also contribute to driving innovation and seeking new technical solutions for R&D portfolio.
Core Job Responsibilities:
- System Owner for GxP applications such as CTMS (BioClinica), Oracle Argus Patient Safety, ComplianceWire, MasterContol and other similarly classified R&D applications.
- Work closely with Associate Director of IT & R&D Applications to lead initiatives to improve IT R&D effectiveness and efficiency
- Responsible for maintaining the validated state of IT R&D applications to ensure compliance to regulatory standards
- Managing a team of staff including programmers, analysts, and managed service providers.
- Selection and procurement of appropriate hardware and software
- Implementing and managing security or integrity and backup procedures and change management
- Identify the criticality of selected application functions and the expected service level goals for application operations and support
- Identify the priority of IT R&D support and project requests that impact the system
- Knowledge of validation lifecycle of GxP computerized systems.
- Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry compliance regulation.
- Establish partnership with Business SME's/end users for project requirements
- Managing IT R&D budgets, corporate software licensing policies and procedures
- Represent as System Owner in the event of Regulatory Audits and Inspections
- Manage R&D administration and operational support including user and security management, provide inputs to process improvements.
- Responsible for timely closure of IT R&D Exception Reports, CAPAs and Deviations
- Responsible for review and approval of IT R&D controlled documents, policies, procedures, Work Instructions and vendor agreements
- Familiar with drug discovery, translational medicine, and the IND/NDA process
- Familiar with Enterprise wide systems LIMS/ RIMS implementation and support
- Familiar with Computer System Validation, SDLC and the Change Control Process in Life sciences industry
- The IT R&D Applications Manager should be comfortable working with Business Owners, IT QA, Business QA and end users with differing levels of technical expertise
- Strong understanding of relational databases, database programming skills and tools
- Expected to deliver documentation and training with all solutions
- Ability to plan and coordinate multiple simultaneous application efforts
- Quick learner, Analytical and problem-solving skills, with ability to work under pressure
- Attention to detail, Self-starter / tenacious problem solver / highly motivated
- Ability to take projects from design to long-term maintenance
- Management and leadership capability
- Excellent communication and documentation skills
- BS in a related field such as Information Technology/ Computer Science/ Software Engineering
- A minimum of 8-10 years practical work experience as an IT System Owner is required with experience in a life sciences/healthcare organization.
- A minimum of 3-5 years practical work experience as an IT System Administrator is required with experience in a life sciences/healthcare organization.
- Working knowledge of FDA, EMA regulations such as Annex 11, 21 CFR Part 11, Part 210, 211; Computer Systems Validation and GAMP framework.
- Must understand the above standards and be able to deliver compliant solutions.
- Reviewing, and executing validation documents within the Computer System Validation
- Familiar with electronic ticketing and document management systems such as: Service NOW, Trackwise, SharePoint and MS- Projects
Equal Opportunity Employer Minorities/Women/Veterans/Disabled