Jill Rodstrom
Global Clinical Development Operations Leader
- Role
- Vice President, Clinical Development Operations at Korro Bio, Inc
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Jill Rodstrom
Executive with 18+ years of hands-on leadership in clinical development operations. Experience scaling clinical operations/clinical development for biotech companies in all phases of drug development in rare disease, oncology, and radiopharmaceuticals. Strategic thinker with strong skills in operational excellence, relationship building, and problem solving. Extensive direct line management experience with strengths in building, integrating and motivating highly productive teams across several departments within clinical development. Below is a brief synopsis of the skills I bring to my work in global clinical drug development. CLINICAL TRIALS Led trial teams through early (pre-IND and phase 1 FIH oncology and NHV studies) to late-stage Proof of Concept, Phase 2 and 3 registration enabling trials in rare disease, oncology, & radiopharmaceuticals. Drove multiple assets to ensure IND readiness through FIH studies, including protocol development, site/CRO selection, and startup timeline compression. Proven expertise in leading successful global pivotal Ph2/3 clinical trials with registrational intent. CLINICAL LEADERSHIP Proven track record of building clinical teams and structures for biotech companies. Adept at developing and operationalizing strategic plans, ensuring compliance, and driving interdisciplinary collaboration to meet aggressive timelines required in biotech environment QUALITY LEADERSHIP Experienced in establishing and maintaining quality infrastructure in early-stage companies, with strong knowledge of GxP regulations. Expert at developing and implementing clinical SOPs, managing Trial Master File (TMF) systems, and overseeing vendor and CRO compliance. Skilled at scaling inspection readiness infrastructure to enable positive FDA/EMA/MHRA inspections PROJECT MANAGEMENT Experienced in strategic planning, team leadership, budget development and oversight, risk management, and resource allocation. Able to drive asset execution by setting aggressive timelines and challenging teams and CRO vendors to meet or exceed goals to accelerate decision making for key clinical assets. REGULATORY OVERSIGHT Skilled in collaborating with regulatory to support IND/CTA submissions. Experience developing, reviewing and functionally approving multiple IND, NDA, MAA submissions resulting in positive outcomes. Functional reviewer of multiple regulatory documents (protocols/IB/DSUR/FastTrack/BTD, ODD). Experienced in CTA submission requirements for global studies. Knowledge of CDx development strategies to support precision medicine assets
Experience
Vice President, Clinical Development Operations
Sep 2025 — Present · Cambridge, MA, US
Education
Grinnell College
BA
MGH Institute of Health Professions
MS
2005 — 2008
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