Head of Clinical & Registry ProgramsDepartment: Specialty Programs
Employment Type: Full Time
Location: Austin, TX
DescriptionWe're building the clinical operations and real-world evidence function that turns that network into a recruitment and biospecimen engine. This starts with observational studies and registries in high-growth, blood-based diagnostic areas such as multi-cancer early detection (MCED) and blood-based Alzheimer's and neurodegenerative testing, and scaling toward interventional research over time. You'll build that capability from the ground up.
We're hiring our first Head of Clinical & Registry Programs to design, launch, and advise on building a multi-site observational registry . This is an in-house, sponsor-side role: you will be the program, not manage a CRO that runs it for you.
You will own the registry from blank page to enrollment: registry design and protocol authoring, central IRB strategy (Advarra/WCG), and internal cross-functional partnership to bring it to life. This is fundamentally about standing up the infrastructure to systematically collect and govern observational data - not running an interventional experiment.
Key Responsibilities- Lead end-to-end registry design and author the registry protocol, charter, informed consent / authorization language, regulatory packets, data dictionary, etc. in partnership with the medical director and steering committee.
- Lead consent and privacy strategy: full consent vs. HIPAA waiver vs. limited data set + DUA. Defend the choice to the IRB and to internal legal/privacy.
- Select and engage the central IRB (Advarra or WCG); negotiate the Master Services Agreement and reliance framework.
- Build and execute the site-activation playbook: feasibility, qualification, site participation agreements, BAAs/DUAs, regulatory packets, training.
- Select and configure the EDC/registry platform (REDCap, Castor, Medidata RWS, or equivalent); spec CRFs, edit checks, and query workflows.
- Stand up the eTMF (Veeva Vault, Florence, or structured equivalent) to DIA TMF Reference Model standards.
- Get to First Subject In within 6-9 months of start.
Skills, Knowledge and ExpertiseRequired- 8+ years in RWE and/or registry programs and/or phase 4 experience
- Has designed and built at least one registry from the ground up - registry design, protocol authoring, and the regulatory/start-up documentation to set it up - whether in an industry/sponsor-side or academic/research setting. Led at least one multi-site observational registry or post-marketing study from protocol through enrollment or has deep experience in phase 4 trials
- Comfortable operating in a data-collection paradigm (observational registries) as distinct from running an interventional experiment - you understand the design, governance, and quality demands specific to systematically collecting longitudinal real-world data.
- Working command of ICH E6(R3) GCP, 45 CFR 46 (Common Rule), HIPAA Privacy/Security, and 21 CFR Part 11.
- Has authored or successfully defended an IRB waiver of consent / waiver of HIPAA authorization.
- Direct working experience with Advarra and/or WCG as central IRB.
- Hands-on with at least one EDC/registry platform (REDCap, Castor, Medidata Rave RWS, OpenClinica, Veeva CDMS).
- Has built and negotiated site participation agreements and BAAs/DUAs at scale (10+ sites).
- Has been through at least one FDA BIMO inspection or rigorous sponsor audit.
- Has significant and direct experience interacting with FDA CBER
Strongly Preferred - Academic or research-institution registry experience (e.g., investigator-initiated or epidemiologic registries), in addition to or alongside industry experience.
- Blood, transfusion medicine, hematology, or apheresis exposure.
- Working knowledge of AABB standards, donor eligibility (21 CFR 630), and blood establishment regulations.
- Experience interacting with FDA, and CBER in particular.
- Start-up or small-company operating experience.
- Familiarity with state privacy law overlays (CCPA/CPRA, WA MHMD, TX HB 300).
Nice to Have- CCRP, CCRA, RAC, or CIP certification.
- Experience with payer/HEOR-driven registries.
- Exposure to eConsent platforms (DocuSign Life Sciences, Medidata Patient Cloud, Castor eConsent).
