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Principal Clinical Scientist, Clinical Development

Delfi

Delfi

Remote
Posted on Wednesday, May 22, 2024
About Us
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.7 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.
Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class
Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.
About the Role:
As Principal Clinical Scientist, Clinical Development you will be responsible for driving the scientific planning, strategy, and clinical management of multiple external research collaborations and clinical trials from early development through publication. The Principal Clinical Scientist will lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management. In this role, the Principal Clinical Scientist will be responsible for leading the cross-functional trial team, including internal and external clinical directors and study managers to lead/support study scientific activities. Additionally, the Principal Clinical Scientist will proactively manage study deliverables and milestones, and identify and resolve clinical study issues, and participate in process improvement initiatives, including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), implementation of study systems, and collaboration with Clinical Quality and Laboratory staff on study compliance initiatives.

What you'll do

  • Responsible for the clinical and scientific execution of clinical protocol(s)
  • Participates in the set up and design during study initiation of internal clinical studies 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
  • Exhibits 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

What you'll have accomplished 12 months from now

  • You will have established an exemplary rapport and relationship with external partners and vendors
  • 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
  • You will have 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 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
  • 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
  • You will have 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
  • You will have assisted with authoring and review of multiple departmental SOPs
  • You will be a respected member of the clinical development team, having contributed to the collaborative delivery of key trials and analyses

What you'll bring to DELFI

  • Bachelor’s degree (or higher) in science or health-related discipline
  • 10 years of clinical research experience and bachelor’s degree; or 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 research projects including development of protocols, case report forms, informed consent and study initiation and monitoring
  • 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
  • Preferred
  • Advanced Degree in a scientific discipline (e.g. MS, PharmD, PhD, MD) strongly preferred
  • Knowledge of medical device clinical trial design, clinical research and best practices from early stage through regulatory submission
  • Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution
DELFI is not open to submissions or partnerships with recruitment agencies or search firms.
An equal opportunity employer
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.