Director, IT

Lakefront Biotherapeutics, Inc.; South San Francisco (CA); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Performance bonus

Comprehensive benefits

Job summary

Lakefront Biotherapeutics, Inc. is seeking an experienced Director of IT to lead day‑to‑day technology operations and deliver the IT roadmap with the VP of IT. This hands‑on role owns end‑user services, business applications, and regulatory compliance for GxP systems.

You will manage MSPs and vendors, drive validation plans to Quality, and partner across Quality, Regulatory, Manufacturing, and Finance to support critical biotherapeutic programs.

Qualifications

• Bachelor's degree in information technology, computer science, or a related field.
• 10+ years in IT, with at least 4 years in a lead or management role.
• At least 5 years supporting biotech, pharmaceutical, or FDA-regulated life sciences.
• Hands-on experience with CSV or CSA, 21 CFR Part 11, and GxP documentation practices.
• Experience administering Veeva Vault in support of Quality and Regulatory functions.

Responsibilities

• Manage MSPs, contractors and IT vendors against defined SLAs.
• Set service standards for end‑user support and measure performance.
• Partner with Facilities on lab/office build-outs and IT requirements.
• Maintain data integrity and ensure GxP systems meet regulatory requirements.
• Own IT SOPs for change control, access reviews, and periodic system reviews.
• Lead Vault configuration, lifecycle, and workflow design for QMS and RIM.

Skills

Leadership

IT strategy

Stakeholder communication

GxP knowledge

Regulatory liaison

Budgeting & cost control

Education

Bachelor's degree in IT/CS or related field

Tools

Veeva Vault

Job description

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.

Our lead asset is being developed for severe immune‑mediated diseases, while additional preclinical programs expand the long‑term potential of our R&D pipeline. At Lakefront, we focus on advancing programs with strong biological rationale, clear clinical proof of concept and large commercial opportunities.

Are you ready to transform lives and be part of a journey like no other? We are building a company where science, execution, and accountability matter. Rather than layers of hierarchy, we operate with small, empowered teams that work hands‑on across development stages to move programs forward efficiently and thoughtfully.

We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact. At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.

If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.

The Role

The Director of IT runs day‑to‑day technology operations for Lakefront Bio and leads delivery of the IT roadmap set with the Vice President of IT. This is a hands‑on leadership role. You will own end‑user services, business application support, and the compliance posture of our systems. You will manage managed service providers (MSPs) and vendors, and you will make sure our GxP‑relevant systems stay validated and inspection‑ready.

You will work closely with Quality, Regulatory Affairs, CMC and manufacturing, Research and laboratory operations, Clinical Operations, Facilities, and Finance. The right person is comfortable troubleshooting a user escalation in the morning and presenting a validation plan to Quality in the afternoon.

What You’ll Do

IT OPERATIONS AND SERVICE DELIVERY

• Manage MSPs, Contractors and IT vendors against defined SLAs, including help desk, onboarding and offboarding, and asset lifecycle.
• Set service standards for end‑user support and measure performance against them for your defined location.
• Help to set that standards for service delivery related to ticket queue creations and KPI metrics reporting.

FACILITIES PARTNERSHIP

• Work closely with Facilities on lab and office build‑outs, renovations, expansions, and site moves, including IT requirements gathering and user readiness.
• Support building technology systems with Facilities, such as badge access control, conference room AV, and visitor management.
• Coordinate support for lab instruments and lab equipment monitoring systems (for example, freezer and environmental monitoring).

GXP SYSTEMS AND COMPLIANCE

• Partner with Quality to maintain a risk‑based computer system validation (CSV) or computer software assurance (CSA) program aligned with GAMP 5.
• Make sure GxP systems meet 21 CFR Part 11 and EU Annex 11 requirements for electronic records, electronic signatures, audit trails, and access control.
• Support GxP systems across manufacturing and laboratory operations (GMP and GLP), including CMC and external manufacturing systems, batch and production records, laboratory data systems, and instrument‑generated records.
• Maintain data integrity practices (ALCOA+) across clinical, manufacturing, and laboratory records, including audit trail review and controlled review and approval workflows.
• Own IT SOPs for change control, access reviews, and periodic system review.
• Represent IT during regulatory inspections, sponsor audits, and vendor qualification audits.

BUSINESS APPLICATIONS

• Own the Veeva Vault platform as a core system of record, including Vault QualityDocs and QMS (document control, change control, deviations, CAPA, and training) and Vault RIM (submissions, registrations, and health authority correspondence).
• Partner with Quality and Regulatory Affairs on Vault configuration, lifecycle and workflow design, document and object migrations, release management, and periodic Vault releases.
• Lead selection, implementation, and support of the wider application portfolio, including eTMF, ELN/LIMS and other laboratory informatics, manufacturing and supply chain systems, ERP and finance tools, and HRIS.
• Coordinate data exchange with CROs, CDMOs, central labs, and other external partners, including controlled exchange of GxP manufacturing and laboratory records.
• Manage integrations, user access, and license use across the application portfolio.

LEADERSHIP AND PLANNING

• Help the VP of IT build the IT strategy, roadmap, and annual budget, then own execution.
• Track IT spend, contracts, and renewals, and find savings where they exist.
• Manage and develop [0–2] IT staff as the team grows.
• Write clear policies and user guidance, and report on service and project status to leadership.

What You Bring

REQUIRED

• Bachelor's degree in information technology, computer science, or a related field, or equivalent experience.
• 10+ years in IT, including at least 4 years in a lead or management role.
• At least 5 years supporting biotech, pharmaceutical, or another FDA‑regulated life sciences company.
• Hands‑on experience with CSV or CSA, 21 CFR Part 11, and GxP documentation practices.
• Experience supporting GxP systems in manufacturing and laboratory settings (GMP and GLP), including data integrity expectations for production and laboratory records.
• Hands‑on experience administering or implementing Veeva Vault in support of Quality and Regulatory functions.
• Strong working knowledge of cloud and SaaS platforms, identity and access management, and endpoint management.
• Track record of managing MSPs and vendors, contracts, and budgets.
• Experience partnering with Facilities on lab or office build‑outs and building systems.
• Clear communication with scientists, clinicians, executives, and auditors alike.

PREFERRED

• Experience at a clinical‑stage company preparing for late‑stage trials, an NDA or BLA submission, or commercial launch.
• Veeva Vault certification, or implementation experience across multiple Vault applications (QualityDocs, QMS, RIM, eTMF).
• Experience with GxP systems supporting external manufacturing partners, including CDMO and contract laboratory data exchange.
• Experience supporting an IPO, SOX implementation, or ITGC audits.
• Certifications such as ITIL or relevant Microsoft credentials.
• Familiarity with lab informatics and instrument data management.

Base compensation for this position ranges from $230,000 - $250,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job‑related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics’ performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.

At Lakefront Biotherapeutics, we are committed to attracting individuals who bring strong expertise, integrity, and a collaborative mindset. We value people who take ownership, work effectively across teams, and want to contribute to meaningful progress.

You will join a highly motivated and supportive team working together to advance our pipeline and strengthen how we operate. As we continue to build and grow, we offer an environment where individuals can develop, take on responsibility, and make a tangible impact.

Lakefront Biotherapeutics is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.