Director of Clinical Data Management

Pathos; New York (NY); Hybrid; USD 200,000 - 240,000; Full time

Job summary

Pathos, an AI-driven biotech company in New York, seeks a Director of Clinical Data Management to build and lead the data management function for oncology trials. You will drive data quality, standards, and regulatory readiness across outsourced studies.

You will shape DMPs/DRPs, collaborate with Biostatistics, Clinical Ops, and Data Science, and partner with Pathos’ AI/ML platforms for integrated data insights.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Data Management, or related field.
• 10+ years of progressive experience in clinical data management, including leadership in oncology trials.
• Deep knowledge of EDC systems (Medidata Rave, Veeva CDMS, Oracle InForm) and CDISC SDTM/ADaM standards.
• Experience gathering requirements and preparation of specifications for database systems and integrations e.g. ePRO, lab data uploads, IVRS/IWRS.
• Knowledge of regulatory and industry standards (ICH/FDA, GCP, CDISC, 21 CFR 11) and NDA/MAA/BLA filing preferred.
• Experience managing CROs/vendors and building CDM functions.
• Strong interpersonal skills to work independently and collaboratively in a dynamic team.

Responsibilities

• Leads oversight of data management for outsourced clinical trials including project management, vendor management, data cleaning process, and approval of deliverables.
• Oversees CRO/Vendor activities to ensure GCP compliance, adherence to protocols and SOPs.
• Maintains data management standards across trials with CRF design, DM Plans, annotations, and database closure.
• Ensures timely database lock, data quality, and readiness for statistical analysis and regulatory submissions.
• Drives adoption of modern, scalable data management tools and workflows.
• Manages CROs and vendors delivering CDM services, ensuring timelines, budgets, and quality.
• Develops and monitors CDM plans (DMPs, DRPs) and data transfer specifications.
• Resolves complex data issues with clinical and statistical teams.

Skills

Leadership

Vendor management

Regulatory knowledge

Cross-functional collaboration

Data standards

GCP compliance

Problem solving

Independent working

Education

Bachelor’s or Master’s degree in Life Sciences or Data Management

Tools

Medidata Rave

Veeva CDMS

Oracle InForm

CDISC SDTM/ADaM

Job description

Drug development shouldn’t be guesswork, not when patients are waiting.

Pathos is an AI and technology company that develops drugs. Foundry, our platform,

decides which ones.

We are not a biotech that uses AI. We are redesigning drug development from first

principles around an AI and technology core. Our Foundation Model reads across DNA,

RNA, pathology, and clinical text on 200+ petabytes of Multimodal data. Our Foundry

platform turns that model into live portfolio decisions: which asset to invest in, which trial

design to pivot, which program to stop. In 2026, every major portfolio decision

at Pathos was Foundry-informed, a Platform-Informed Decisions score of 4 out of 4.

The three engines of the platform are Scout (finds assets other companies would miss),

Foundry (decides where capital and clinical attention go), and Sprint (executes trials with

AI agents doing the work that used to require a full biotech). We call it a biotech

company in a box.

We are well-capitalized. We have three clinical-stage oncology programs, and a co-development partnership with a top-five pharma. Our leadership has

nearly two decades of company-building experience and multiple successful exits behind

them.

How We Build

Pathos does not operate like a traditional biotech. There is no middle management.

There are no layers of approval. Every function, Clinical, Legal, Finance, Regulatory,

Engineering, Research, is built the same way: small teams of 3-5 subject matter experts,

each commanding 30-50 AI agents to do the work that used to require dozens of people.

Everyone builds. Everyone ships. Product velocity is measured in hours, not weeks. A team of 40-50 operators does the work of a traditional biotech of 300. Every dollar saved

on overhead is a dollar deployed into a clinical program.

The people who thrive here are operators: deep experts who can specify what needs to

happen, orchestrate AI agents to execute at scale, and make high-judgment calls that

compound over time. If you have spent your career building and shipping in your

domain, this is the environment where that experience becomes a superpower.

About the Role

The Director of Clinical Data Management (CDM) will establish and lead the data management function at Pathos. This role reports to the Chief Clinical Operations Officer and is ideal for a hands-on data leader who thrives in high-growth, fast-moving environments and is excited to build CDM strategy, systems, and processes from the ground up.

You will own oversight of clinical data collection, cleaning, and integrity across our oncology trials, ensuring datasets are of the highest quality for analysis, regulatory submissions, and decision-making.

Key Responsibilities

Clinical Data Strategy & Oversight

• Leads oversight of data management for outsourced clinical trials including project management, vendor management, coordination of internal reviews and data cleaning process, and approval of deliverables.
• Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
• Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check programs/specifications, data entry and query status tracking, and database closure.
• Ensure timely database lock, data quality, and readiness for statistical analysis and regulatory submissions.
• Drive adoption of modern, scalable data management tools and workflows.
• Manage CROs and vendors delivering CDM services, ensuring compliance with timelines, budgets, and quality standards.
• Develop and monitor CDM plans, including Data Management Plans (DMPs), Data Review Plans (DRPs), and data transfer specifications.
• Resolve complex data issues, queries, and discrepancies in collaboration with clinical and statistical teams.

Cross-Functional Collaboration

• Serve as the primary CDM representative on cross-functional study teams.
• Partner with Biostatistics, Clinical Operations, Clinical Development, and Data Science colleagues to ensure data supports trial endpoints and regulatory deliverables.
• Collaborate on integration of clinical trial data with Pathos’ AI/ML platforms and real-world data sources.

Leadership & Compliance

• Build and scale the CDM function, including hiring and mentoring staff.
• Develop SOPs, best practices, and quality frameworks to ensure compliance with GCP, ICH, and regulatory requirements.
• Contribute to portfolio-level planning and operational strategy.

What We’re Looking For

• Bachelor’s or Master’s degree in Life Sciences, Data Management, or related field.
• 10+ years of progressive experience in clinical data management, including leadership in oncology trials.
• Deep knowledge of EDC systems (e.g., Medidata Rave, Veeva CDMS, Oracle InForm) and clinical data standards (CDISC, SDTM, ADaM).
• Experience in gathering requirements and preparation of specifications for database systems and integrations e.g. ePRO, laboratory data uploads, supply management, IVRS, IWRS, etc. would be highly regarded.
• Knowledge of regulatory and industry standards (e.g. ICH/FDA guidelines, GCP, CDISC standards, GCDMP, 21 CFR 11, MedDRA and WHO Drug dictionaries etc.) and their application to Data Management practice. Prior experience filing a NDA/MAA/BLA preferred
• Experience managing CROs/vendors and building CDM functions preferred
• Proven ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team

Location

This is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.

The pay range for this role is:

200,000 - 240,000 USD per year (New York Office - ACLS East Tower)