Medical Director

DELFI Diagnostics Logo

DELFI Diagnostics

πŸ“Remote - Worldwide

Summary

Join DELFI Diagnostics, a company developing next-generation blood-based cancer detection tests, as a Medical Director/Senior Medical Director in Clinical Development & Medical Affairs. Collaborate with internal teams and external experts to advance understanding of DELFI's clinical research and technology. Support the generation of product-related evidence through various initiatives, including investigator-led studies and real-world evidence registries. Play a key leadership role in DELFI's clinical development program, interacting with study sites and collaborating on protocols. The position requires a medical degree (MD, DO, or equivalent) with 5+ years of clinical practice and experience in clinical trial implementation. The role involves contributing to clinical trial protocols, monitoring plans, and CRF development, ensuring clinical compliance and high scientific standards. The successful candidate will also foster relationships with key opinion leaders and present at scientific conferences.

Requirements

  • Medical degree (MD, DO or equivalent) with 5+ years of clinical practice
  • Prior clinical trial implementation experience in Pharma or Medical Devices
  • Thorough understanding of medical practice and diagnosis related to pulmonology, cancer care or screening
  • Knowledge of regulatory and GCP elements of clinical trials
  • Excellent organization, communication, presentation, critical thinking, and interpersonal skills
  • Ability to influence and build and foster relationships horizontally and vertically across the organization
  • Ability to communicate with senior leadership, clinicians, and regulatory authorities
  • Excellent writing and presentation skills required
  • Availability for up to 25% business travel

Responsibilities

  • Serve as expert clinical contributor within the company regarding clinical use and enhancements of current and potential DELFI technologies
  • Contribute to the protocol, monitoring plan, and CRF development for DELFI clinical trials by working collaboratively with Clinical Operations, Clinical Data Management, Statistical Science, Medical Communications, and Regulatory groups at DELFI
  • Regularly engage expert advisors on matters of study design and endpoints
  • Ensure execution of clinical trials in support of DELFI’s clinical evidence strategy
  • Provide project team training on disease and/or therapeutic areas
  • Executed on DELFI clinical studies, acting as medical monitor, facilitating execution and data interpretation
  • Lead the preparation of clinical study reports for on-going studies, provide medical input for publications and support Regulatory strategy, including submissions
  • Provide internal education and clinical insight to help refine DELFI product use applications
  • Closely monitored and ensured clinical compliance and high scientific standards in ongoing trials
  • Fostered relationships with KOLs in US and internationally for the assessment of DELFI technology, evidence evaluation and clinical guidelines, including relevant clinically focused advocacy organizations
  • Supported the launch of at least one investigator initiated study
  • Presented at several relevant scientific conferences and medical meetings
  • Provided evidentiary structure and helped design and prepare registry of DELFI technology in real world use
  • Provided registry guidance for new products

Preferred Qualifications

  • Prior experience in vitro diagnostic diagnostics development
  • An advanced degree in public policy or public health
  • Molecular diagnostics, genetics, or related scientific field background

Benefits

$220 - $325 a year

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