Sr. Director/Head of Data Management

ALX Oncology Inc.•South San Francisco, CA

9d•$240,000 - $280,000

About The Position

The Head of Data Management (Senior Director) is a key leadership role in a lean biotech company responsible for establishing and leading the Clinical Data Management function. This role will provide both strategic direction and hands-on execution to ensure high-quality clinical trial data that supports critical development milestones and future regulatory submissions. In a small biotech environment, this leader must be comfortable operating with limited internal infrastructure, leveraging CRO and vendor partnerships, building pragmatic processes, and personally driving priorities when needed.

Requirements

Bachelor’s degree in Life Sciences, Statistics, Computer Science, or related discipline required.
10+ years of clinical data management experience in biotech, pharma, or CRO settings.
At least 6 years of overall experience require acting as a project lead data manager
Prior leadership experience with responsibility for outsourced studies and vendor oversight.
Experience in small biotech or resource-focused environments strongly preferred.
Experience supporting Phase I/II/III studies required; Phase IV and submission experience a plus.
Strong knowledge of EDC systems such as Medidata Rave, Veeva EDC, or Oracle platforms.
Solid understanding of data cleaning, coding, external data reconciliation, and database lock.
Familiarity with CDISC standards and submission expectations.
Strong vendor governance and budget management skills.
Hands-on and comfortable working with focused internal teams.
Practical, solutions-oriented, and able to prioritize effectively.
Strong communicator who can influence across functions and with external partners.
Ability to communicate in written and oral forms.
Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.
The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
Must be able to use the telephone and communicate clearly with a host of external individuals, domestically and globally.
Ability to work at a computer for extensive periods of time.
Ability to work in a fast-paced working environment managing multiple tasks.

Nice To Haves

Advanced degree preferred.
Experience in Oncology and/or Immuno-oncology trials preferred

Responsibilities

Serve as the functional lead for all Clinical Data Management activities across the development portfolio.
Provide input into Biometrics strategy and implement department initiatives
Build fit-for-purpose processes, standards, templates, and governance appropriate for a lean organization.
Develop a roadmap for scaling the function as programs advance.
Assess future hiring needs and organizational design as portfolio complexity increases.
Interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner.
Provide day-to-day oversight of outsourced data management activities for ongoing clinical studies.
Review and approve key deliverables including eCRFs, edit checks, data review plans, coding conventions, reconciliation plans, and database lock plans.
Act as internal escalation point for data issues impacting timelines, quality, or study milestones.
Lead data review, issue triage, and milestone readiness activities as needed.
Lead management of CROs and specialty vendors providing EDC, eCOA/ePRO, coding, central labs, and related services.
Establish clear expectations, timelines, governance cadence, and performance metrics.
Ensure vendors remain aligned to company priorities and operate with urgency.
Manage budgets and identify cost-efficient solutions without compromising quality.
Work closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Science, Medical, Safety, Regulatory, and Quality team members.
Support protocol development by advising on data collection strategy, endpoint feasibility, and operational practicality.
Ensure data readiness for interim analyses, safety reviews, DSMB meetings, and topline readouts.
Oversee EDC and related data systems selection, configuration strategy, and vendor management.
Implement streamlined processes that minimize burden while maintaining compliance.
Introduce dashboards and metrics to improve visibility to study progress and data quality.
Maintain documentation and processes that support diligence reviews, audits, and future inspections.