Vice President, Clinical Development
Clinical Development – Clinical Development /
Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.
Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.
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.
In this role you will work collaboratively, both internally and externally, to develop, implement, and oversee clinical trials of Delfi technology. This role will work extensively with internal clinical trial operations, external advisers and investigators, and regulators to ensure clinical studies are executed using robust designs, conducted in relevant populations, and adhere and exceed compliance standards for regulatory submission.
What you'll do
- What you’ll do internally:
- Oversee clinical trial protocols, monitoring plans, CRF development working in concert with Clinical Operations, Clinical Data Management, and Statistical Science
- Oversee clinical evidence strategy supporting and advancing Delfi products through the Medical Affairs team
- Actively engage with and work in partnership with regulatory groups at Delfi
- Contribute to strategic planning activities by anticipating shifting clinical needs and comprehending competitive landscape
- Play a lead role in due diligence activities surrounding new opportunities
- Provide leadership of clinical development and affairs, including clear communication of objectives, the development of key strategies and tactics, and oversight of performance on a daily basis
- Hold accountability for all clinical study related expenditures, and assist in forecasting, planning and execution of future budgets
- Lead clinical trial implementation with sites in collaboration with medical directors, clinical operations and clinical data management
- Regularly attend investigator and advisor meetings, to enhance awareness of studies and findings evaluating Delfi technology
- Establish and maintain relationships with key academic and community based clinical institutions, physician and clinical trial and demonstration project site investigators, third party clinical trial companies, disease advocacy groups, in furtherance of clinical evaluation of Delfi technologies pre and post launch
- Represent the Company in scientific and academic settings with financial analysts, investors, key opinion leaders, medical experts, and partners
- Develop and deliver educational content
What you’ll do externally:
What you'll have accomplished 12 months from now
- Built network of collaborators and KOL’s to help assess Delfi products
- Maintained and improved coordination and execution of ongoing Delfi clinical studies
- Designed and set up networks to launch US and international clinical trials
- Presented at several scientific conferences and medical meetings
- Provided internal education and clinical insight to help refine Delfi product use applications
- Closely monitored and ensured compliance and high scientific standards in ongoing studies
What you'll bring to DELFI
- Advanced degree with 10+ years of experience leading and overseeing clinical development and investigator sponsored studies in diagnostics
- Thorough understanding and sophisticated lexicon of cancer screening and clinical data elements
- Deep knowledge and operational experience regarding regulatory and GCP elements of clinical trials
- Availability for frequent national and occasional international business travel
- Excellent organization, communication, presentation, critical thinking, and interpersonal skills
- Ability to influence, build and foster relationships horizontally and vertically across the organization
- Ability to communicate with senior leadership, clinicians, investors, and regulatory authorities
- Excellent writing and presentation skills
- An advanced degree (MD/PhD) in public policy or public health
- Molecular diagnostics, genetics, or related scientific field background
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.