Senior Clinical & Safety Scientist, Oncology/Hematology (MD/Non-MD) Medical & Pharmacovigilance US

Senior Clinical & Safety Scientist, Oncology/Hematology (MD/Non-MD) Medical & Pharmacovigilance Full Time USA (Remote) About the Role The Senior Clinical & Safety Scientist, Oncology/Hematology (MD/Non-MD) at Pi Health is a pivotal, high-impact individual contributor (Senior Manager level) who brings together clinical science leadership and proactive patient safety oversight across our oncology and hematology portfolio. Working closely with, and under the medical guidance of, the Medical Monitor, clinical operations, biostatistics, and regulatory colleagues, this role supports the scientific conduct, analysis, and reporting of early-phase (Phase I–II) oncology trials while serving as a trusted safety voice: monitoring emerging safety data, evaluating signals, and contributing to key safety documents from first-in-human through proof of concept. The ideal candidate combines rigorous scientific judgment, a genuine commitment to patients, and enthusiasm for innovative, data-driven approaches to drug development. What You'll Do Clinical trial leadership: Accountable for the clinical science aspects of one or more oncology and hematology clinical trials, with emphasis on early-phase (Phase I–II) and first-in-human studies, in close partnership with the Medical Monitor, clinical operations lead, and cross-functional colleagues Study design and key documents: Contribute to sponsor-led clinical trial protocols and amendments, Investigator's Brochures (including the Reference Safety Information), informed consent forms, IND sections, DSURs, CSRs, and other regulatory documents, publications, abstracts, and presentations Safety surveillance: Conduct ongoing medical safety surveillance of active trials, including routine review of individual subject and cumulative safety data, to identify, evaluate, and manage potential safety signals Case review: Review individual case safety reports (ICSRs) and serious adverse events, including SAE processing, reconciliation, and follow-up with sites. MD incumbents provide physician-level assessment of causality and expectedness; Non-MD incumbents perform scientific case review, with final medical assessment by a physician in accordance with Pi Health SOPs Safety plans and documentation: Maintain study-level safety and medical documents, including Safety Management Plans (SMPs) and Medical Data Review Plans (MDRPs); draft DSUR sections for Medical Monitor review; and support medical coding queries with Data Management Signal detection and benefit-risk: Support signal detection and evaluation for assigned studies, contribute to ongoing benefit-risk assessment, prepare safety data for Safety Monitoring Committees and sponsor safety governance, and help implement resulting updates to reference safety information and other key safety documents Safety review of study documents: Review protocols, IBs, ICFs, and related materials to ensure alignment with the product safety strategy, appropriate risk mitigation measures, and clear risk communication Data review and interpretation: In collaboration with the Medical Monitor and, where assigned, the biostatistician, review, analyze, and interpret clinical trial data, including preparation of safety tables, listings, and SMC data packages; accountable for the safety components of CSRs, aggregate reports, publications, and other regulatory documents Regulatory support: Support sponsor regulatory filings (e.g., IND, NDA, BLA) and responses to safety queries from health authorities and other third parties Study execution: Partner with Clinical Operations on timely, high-quality execution of first-in-human through proof-of-concept programs, including support of site initiation visits and investigator meetings, enrollment pack and eligibility data preparation, query resolution, and training of sites and internal teams on safety-related procedures and policies Product and competitive knowledge: Develop and maintain a deep understanding of the safety profile of assigned products, relevant drug classes, competitor safety issues, and pertinent scientific literature External engagement: Build strong working relationships with investigators, site staff, sponsor study teams, and vendors; prepare sponsor- and site-facing responses for Medical Monitor review and sign-off; and present clinical and safety data summaries to internal and external stakeholders Process excellence: Represent clinical and safety science at internal cross-functional team meetings and contribute to SOP development and continuous improvement of Medical and Pharmacovigilance processes, including user acceptance testing of safety dashboards and automated safety workflows Qualifications Advanced degree in a life science or health discipline (e.g., PhD, PharmD, MSc, or advanced nursing degree such as MSN/NP/DNP); or Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent, with oncology or relevant therapeutic specialty experience in an academic or hospital setting preferred 3–5+ years of drug development experience in the pharmaceutical, biotechnology, or CRO industry, including at least 2 years in clinical science and/or drug safety roles; oncology experience strongly preferred Demonstrated experience overseeing, developing, or executing oncology or hematology clinical trials, ideally in early phase Solid working knowledge of pharmacovigilance and safety science, including GCP, GVP, ICH E2 guidelines, and US, EU, UK, and other regional safety reporting requirements (e.g., 21 CFR 312.32) Familiarity with related disciplines, including clinical operations, biostatistics, regulatory affairs, and clinical pharmacology Strong ability to analyze, interpret, and present trial-level and aggregate data and to identify meaningful trends Proven scientific and medical writing skills, with excellent verbal communication and presentation skills Demonstrated ability to lead and influence with and without authority, build consensus, and drive change across all levels of the organization, including senior management Comfortable in a CRO setting, working closely with sponsor teams, investigators, and site staff, and aligning with the Medical Monitor before sponsor- or site-facing communication Detail-oriented and highly organized, with the ability to prioritize and work independently in a fast-paced environment Critical thinker who is proactive, with a highly collaborative, team-focused approach Genuine interest in AI, automation, and digital innovation, with willingness to help test and shape new safety tools Proficiency with Microsoft Office Experience with EDC systems (Pi Health uses its proprietary FICS platform), safety databases (e.g., Argus, ArisGlobal LifeSphere), MedDRA coding, and data review or visualization tools (e.g., Spotfire, JReview) preferred Details USA (Remote) position; open to US-based applicants only Full time; 40+ hours/week, overtime may be required on occasion Travel: up to 10%, including vendor and stakeholder meetings, internal collaboration, investigator meetings, industry conferences, and regulatory inspections Reports to the Executive Medical Director; no supervisory responsibilities Pi Health is an equal opportunity employer. #J-18808-Ljbffr