Who Are We?
Founded in 1997 and built upon 26+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.
Who Are You?
You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.
If this sounds like you, we are currently seeking an Associate Director, IT Infrastructure & Security to add to our team!
Your Main Responsibilities and Duties Include:
- Plans and manages growth of IT infrastructure.
- Manages the IT inventory and ensure that all hardware and software is maintained and supported.
- Manages IT equipment acquisition and set-up and decommission for all employees.
- Supports QA in pre-implementation, implementation and post-implementation activities of Clinical, Quality and Regulatory data system validations.
- Support GxP electronic system lifecycle program.
- Implements companywide cybersecurity training system with support from MSP.
- Serves as IT business process owner and subject matter expert during audits.
- Develops and maintains IT and security policies and standard operating procedures.
- Assists in development of Cybersecurity Incident Response Plan and conducted tabletop exercises.
- Oversees business continuity and contingency planning for all technology cyber security and information systems.
- Oversees and ensures effective collaboration with vendors and manages IT vendor performance.
- Supports IT Vendor in troubleshooting hardware and software issues.
- Manages and supports remote and mobile connectivity for staff.
- Manages Microsoft 365 rollout & implementation in coordination with MSP.
- Collaborates with other technical management/MSP to identify, implement and maintain new innovations and industry standards for IT infrastructure management, deployment, and change management.
- Ensure data integrity elements are upheld with system access and information management.
- Provides day-to-day support for internal customers and system users.
- Additional duties as required.
To Succeed in this Position:
- You will have a Bachelor’s degree in IT, Cybersecurity or related discipline or equivalent number of years of work experience.
- You will possess a minimum 8 years direct IT experience in roles of increasing responsibility in project/program management, IT management ideally within a life sciences organization.
- You will have experience with GxP environment; computer system validation, change management, and discrepancy reporting is preferred.
- You will have a strong working knowledge of current 21 CFR Part 11 requirements
- You will have the ability to lead Computerized System Validation (CSV) and Computerized Software Assurance (CSA) efforts as the IT business process owner
- You will possess strong knowledge of Microsoft server technology stack including Active Directory, MS SQL, SSO, MFA, and Windows. Preferred knowledge of JAVA, MS ACCESS, MS Project, MS Teams, SharePoint, ComplianceWire, and eTMF.
- You will be able to demonstrate a history of managing complex projects to completion to strict timelines and budgets using IT industry standards. Experience in Microsoft 365 Implementation is a plus.
- You will have a strong foundational knowledge of IT infrastructure concepts, architecture and best practices including data center facilities, OS, hypervisor, network, storage, and security.
- You will have the ability to support mission-critical business solutions.
- You will ensure established IT program processes and governance are followed and that established standards are met.
- You should be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and ability to adapt and learn to changing business environment and domains is a must.
** Please note that this is a hybrid position that is currently required to be onsite three days a week (Tues-Wed-Thurs).
The most likely starting base pay range for this position is $95,000 - $125,000 per year. Several factors, such as experience, tenure, skills, and business needs will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.
We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
