Director, IT Business Partner (Clinical Dev & Manufacturing)

Position Summary

The Director, IT Business Partner is a strategic business partner who shares ownership of both strategy and results for Quality, Regulatory Affairs, Manufacturing and Supply Chain, and Pharmacovigilance (PV) and Drug Safety. The Director will serve as a strategic partner and advisor by fostering a strong strategic relationship between business stakeholders and IT. The Director will advocate for and lead IT business needs and portfolio management.

This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Director will report to the Senior Director, IT Business Systems.

Primary Responsibilities 

• Establish strong relationships with business functional leaders and stakeholders to understand strategy needs and execution plans 
• Act as the primary contact for Quality, Regulatory Affairs, Manufacturing and Supply Chain, and PV and Drug Safety teams to help establish a strategy, manage a roadmap, contribute to the annual budget and LRP processes, and drive the delivery of new and enhanced capabilities in these areas
• Actively participate as a member of the IT leadership team that will help establish standards, governance, and demand planning, while ensuring alignment with corporate objectives
• Remain up to date on emerging and innovative technologies which may enable or disrupt business capabilities, and provide counsel to stakeholders when developing strategy and roadmaps
• Provide or assist project management for new systems and services related to the functional and technical requirements in business functional groups, in accordance with the IT project lifecycle framework
• Establish partner/vendor management strategy to elevate vendor/partner performance and value, including establishing and managing application support models
• Ensure the appropriate regulatory and compliance regulations are met and accounted for with the client groups’ app portfolio (e.g., GxP, SOX, GDPR, etc.)
• Manage all aspects of solution delivery, such as project management testing, documentation, qualification, etc. and assist in the writing and management of controlled processes 

Competencies 

• Excellent knowledge of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV) and GAMP5 guidelines
• Ability to multi-task and meet deadlines in a fast-paced, changing environment 
• Self-starter with hands-on attitude and the ability to think out-of-the-box 
• Ability to negotiate conflict and problem solve
• Ability to lead change using positive and collaborative methods

Experience

• Bachelor’s degree in computer science, information technology, or related discipline required
• 9+ years’ experience in business partnership, system implementation, and project management 
• 6-8 years’ experience in a commercial-stage company in the pharmaceutical or biotechnology industry
• Experience with applying business and systems needs within Europe, taking into consideration the particular regulatory requirements
• Third party vendor/partner and contract management experience 
• Project management experience, including requirements gathering and documentation, vendor selection, implementation, and change management 
• Experience as a business analyst, including identification of non-technical business requirements and translating specifications into solution designs
• Experience with key systems in business domain, including but not limited to QMS, RIM, eTMF, SAS, Safety Data
• Experience with building and maintaining business partner relationships, strategy planning, and roadmap building and execution
• Proven track record of administering GxP systems and thinking holistically about the business processes critical to company success across multiple systems and departments

EEO Statement: 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. 

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions.  Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan.  Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events.  Geron recognizes that its employees work in many different states and therefore may be affected by different laws.  It is Geron’s intention to comply with all applicable federal, state, and local laws that apply to the Company’s employees.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background.  The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed.  Please note the employment opportunity is not limited to these locations. 

General Salary Range: $200,000 to $220,000