Head of Clinical & Registry Programs

Join Parachute operates a national, software-enabled biologics platform with 55 plasma and blood collection centers across 20 states, serving over 500k donors. That footprint is the foundation for a longitudinally-engaged donor population that can power the next generation of blood-based clinical research. We'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 Expertise Required 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).