Principal Clinical Scientist

Summary

Join DELFI Diagnostics, a company developing next-generation cancer detection tests, as a Principal Clinical Scientist. You will be responsible for the scientific planning, strategy, and clinical management of DELFI-sponsored studies and external research collaborations. This role involves leading cross-functional teams, managing study deliverables, and ensuring compliance with regulatory requirements. The ideal candidate will have a Master's degree (or higher) in a science or health-related discipline and significant experience in clinical trials and research. DELFI offers a competitive salary and benefits package. The position requires approximately 10-15% travel.

Requirements

• Master’s degree (or higher) in science or health-related discipline
• 8 years with a Master’s degree; or 5 years experience with a PhD; or equivalent experience
• Demonstrated ability to drive and manage scientific activities on clinical protocols with analytical skills to interpret data and synthesize conclusions
• Significant experience with clinical trials and clinical research projects including development of protocols, case report forms, informed consent, study initiation and monitoring, and answering site questions on eligibility
• Significant experience with data integrity, exploration, analysis and presentation
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements in clinical research
• Excellent written and verbal communication skills demonstrated by an ability to present complex scientific concepts with clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
• Excellent organizational and interpersonal skills to manage multiple priorities and external relationships within various research collaborations
• Ability and willingness to travel ~10-15% of the time

Responsibilities

• Responsible for the clinical and scientific execution of clinical protocol(s) and/or external research collaborations
• Participates in the set up and design during study initiation of DELFI sponsored clinical trials or external study collaborations (e.g. protocol development, database set up)
• Coordinate and manage production of key deliverables for external research collaborations and clinical studies to ensure study completion to achieve scientific and regulatory goals
• Identify barriers to timely and successful study execution and propose solutions, with regular reporting of study performance metrics
• Assists with and may author/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support the development of regulatory documents
• Exhibit strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supports identification and/or identifies critical risks and mitigations
• Promote consistent first line medical/clinical data review techniques and conventions across assigned studies; Review clinical data review plan and medical monitoring plan for assigned studies
• Manage internal resources, external partners, consultants, vendors, and internal/external budgets to ensure the timely and cost-effective implementation of the clinical strategy for one or more clinical studies
• Manage all clinical aspects of external research collaborations, as needed: budget and metrics; operations; study document development and review (study specific plans, eCRF Guidelines, lab manuals, etc.)
• Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements (knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management is required)
• Maintain proficiency in understanding of early detection practices within oncology and an in-depth knowledge of molecular testing practices within multiple cancer types
• Lead medical monitoring team in review and interpretation of clinical data, protocol deviations in collaboration with the Medical Director
• Overseen the execution of site training, either performed by DELFI Diagnostics or CRO partners, and ongoing educational interventions to assure compliance with study protocols, as appropriate
• Ensured external collaborations and clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations: participate in the planning of quality assurance activities and coordinate resolution of audit findings of vendors and CROs; ensure audit-ready condition of clinical trial documentation
• Supported Senior Management by reviewing the unique enrollment requirements for a clinical study and provided a strategy for successful trial enrollment and completion
• Led the medical monitoring team in review and interpretation of clinical data, and supported the Medical Director in responding to sites/collaborators about eligibility, reviewing data listing, drafting reports/publications on clinical analyses
• Consulted with cross-functional teams on data collection, regulatory questions, and protocol execution as it pertains to the DELFI assay
• Contributed to the scientific design, execution, and publication of studies to support DELFI evidence generation strategy
• Established and maintained effective communication and collaboration with functional area peers, including research, clinical lab operations team, regulatory, quality assurance, and commercial, as well as thought leaders to meet program objectives
• Taken ownership of the financial aspects of assigned program(s) and trial(s) including collaboration with finance partners to generate and review forecasts and accruals and escalates variances as appropriate
• Assisted with authoring and review of multiple departmental SOPs

Preferred Qualifications

• Advanced Degree in a scientific discipline (e.g. PharmD, PhD, MD) strongly preferred
• Knowledge of medical device clinical trial design, clinical research and real world data
• Prior clinical trial management experience with good knowledge of set-up, organization and execution of clinical trials in a pharmaceutical company or contract research organization (CRO)

Benefits

• $190,000 - $210,000 a year
• Total Compensation at DELFI is a combination of salary, bonus, equity, and benefits