Rusti Restaino, DNP, MBA, PMHNP-BC

Senior Clinical Scientist & Principal Medical Writer (Biopharmaceutical Consultant) @ Independent Consultant at Various Companies

About

I offer a rare combination of clinical judgment, business acumen, and clear scientific communication across diverse therapeutic areas, with a strong emphasis on advanced cell therapy. As a DNP‑prepared, board‑certified PMHNP and senior clinical scientist with 10+ years in industry, my experience spans oncology, hematology, autoimmune disease, neurology, anti‑infectives, vaccines, and cell therapies in pharma and CRO settings. I support Phase 1-4 trials through clinical data review and quality oversight, protocol and GCP adherence, and safety and efficacy assessment in close collaboration with clinical, safety, biostats, regulatory, and operations teams, including multiple global cell therapy programs. I also contribute to AI‑enabled initiatives (such as proof‑of‑concept efficacy narratives and data review workflows), helping teams explore practical applications of emerging tools in clinical development. I author submission‑ready safety and efficacy narratives, CSRs, protocols, IBs, DSURs, CTD clinical modules, and RWE reports, drawing on an MBA, a BS in Journalism, and 10+ years in corporate state and local tax consulting that sharpened my project management skills, stakeholder engagement experience, and ability to get complex deliverables over the finish line.

Country

United States

City

New York City Metropolitan Area

Industry

Pharmaceuticals

Skill

Oncology Clinical Research, Clinical Study Design, Clinical Pharmacology, Clinical Research Experience, Medical Research, Pharmaceutical Research, Clinical Data Management, Clinical Data Analysis, Regulatory Compliance, Artificial Intelligence (AI), Regulatory Submissions, Contract Research Organization (CRO), Good Clinical Practice (GCP), Communication, Clinical Protocols, Clinical Research, Healthcare, Inpatient, Patient Safety, BLS

Experience

Senior Clinical Scientist & Principal Medical Writer (Biopharmaceutical Consultant)

Independent Consultant at Various Companies

2024-11 - Present · 1 yr 11 mos

North America

• Delivering specialized Clinical Science and Medical Writing support to biopharmaceutical partners across diverse therapeutic areas, including Oncology, Cell Therapy, Cardiovascular, and CNS/Neuroscience. • Clinical Science: Lead and supporting Clinical Scientist roles across global late-phase oncology programs in ADCs for hematologic indications and a multicenter early-phase CAR T program in solid tumors, with responsibilities including protocol implementation, patient-level data review, eligibility and efficacy confirmation, safety review committee support, cross-functional safety discussions, and clinical interpretation to ensure protocol adherence and inspection-ready documentation. • Medical Writing: Authoring regulatory documents (CSRs, Protocols) and clinical narratives for commercial-stage biopharma clients. • Therapeutic Versatility: Leveraging a DNP in Psychiatric Nursing and recent consulting work to support teams in Cardiovascular and Neuroscience indications, providing cross-functional expertise beyond the oncology space.

Senior Clinical Research Scientist - Cellular Therapy

Bristol Myers Squibb

2021-12 - 2024-11 · 3 yrs

Hematology/Oncology • Transitioned from medical writing to Sr. Clinical Research Scientist - Cellular Therapy role to drive clinical execution for cell therapy program. • Instrumental in the accelerated approval of liso-cel (Breyanzi) in CLL. • Led complex safety and efficacy data reviews, including resolution of clinical queries, and preparation and finalization of safety and efficacy narratives for submission. • Served as primary point of contact for medical data review and safety trends.