Sr. Director/Head of Data Management at ALX Oncology Inc.

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Aug, 26

Salary

280000.0

Posted On

19 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Vendor Oversight, CRO Management, EDC Systems, CDISC Standards, Database Lock, Budget Management, Cross-Functional Leadership, Oncology Trial Experience, Data Cleaning, Regulatory Submissions, Strategic Planning, Process Optimization, Inspection Readiness, eCRF Development, Data Review

Industry

Biotechnology Research

Description

POSITION SUMMARY: 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. This position will report to the Head of BioMetrics. PRIMARY RESPONSIBILITIES AND DUTIES: * Functional Leadership & Buildout * 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. * Hands-On Study Execution * 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. * CRO & Vendor Oversight * 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. * Cross-Functional Partnership * 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. * Systems & Process Optimization * 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. * Inspection Readiness & Corporate Support * Maintain documentation and processes that support diligence reviews, audits, and future inspections. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES: * Education * Bachelor’s degree in Life Sciences, Statistics, Computer Science, or related discipline required. * Advanced degree preferred. * Experience * 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. * Experience in Oncology and/or Immuno-oncology trials preferred * Technical Expertise * 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. * Leadership Style * 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. SALARY RANGE: $240,000 - $280,000 DOE PHYSICAL DEMANDS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. * 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 travel 25% of the time without restriction, domestically and/or internationally. * 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. WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS: We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth. ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position. ABOUT ALX ONCOLOGY ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, Evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and potential to be both first and best in class. For more information about us, please visit www.alxoncology.com [http://www.alxoncology.com/].

Responsibilities

Establish and lead the Clinical Data Management function, providing both strategic direction and hands-on execution for clinical trial data. Oversee CROs and specialty vendors to ensure high-quality data delivery and regulatory compliance across the development portfolio.