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

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

Technology Skills

• 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