Senior Director, Program Management
Senior Director, Program Management
Posted on :
17-06-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
17-06-2025
Job Description
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 99.8 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.
DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices
About Us
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.
About the Role
The Senior Director Program Management provides strategic leadership across DELFIs portfolio working closely with executive leadership and cross-functional teams including R&D clinical quality and regulatory. This leader defines and shapes the comprehensive program strategy for all DELFI product lines while establishing company-wide program management frameworks. The role requires deep collaboration with both internal and external partners to support a clear extensible technology roadmap that advances DELFIs mission. Beyond facilitating critical stage gate and design reviews for both IVD and CAP/CLIA products/services this position drives strategic decision-making ensures operational excellence and manages a team to deliver successful outcomes from R&D through the Product Development Process. This leadership role directly influences strategic direction while translating corporate objectives into actionable program plans that meet regulatory requirements in a rapidly evolving industry.
What Youll Do
- Define and execute comprehensive program strategies across all DELFI programs
- Partner with executive leadership to align program objectives with corporate vision
- Partner with a commercial product manager to translate target product profiles into viable program and project timelines and milestones.
- Identify assess and manage potential risks and dependencies across the project portfolio
- Ensure strict adherence to regulatory requirements (e.g. FDA CAP/CLIA ISO) and quality standards throughout all programs
- Lead critical stage-gate and design reviews for both IVD and CAP/CLIA products/services
- Serve as the central point of contact for cross-functional teams in R&D clinical operations regulatory affairs quality manufacturing and commercial ensuring alignment in budget risks and timelines
- Adjust program schedules and targets as needed to optimize outcomes
- Mentor develop and lead a team of program/project managers and business analysts fostering a culture of accountability collaboration and continuous improvement.
- Build and drive process optimization and innovation within the PMO to enhance efficiency and effectiveness.
Who You Are
- Advanced degree (Ph.D. MD or equivalent) in a relevant scientific discipline (e.g. Molecular Biology Oncology Bioengineering) or MBA preferred.
- PMP or equivalent project management certification required.
- 10 years experience in project management leadership roles preferably in the in vitro diagnostics or biotechnology industry with a focus on liquid biopsy or cancer diagnostics.
- 5 years experience developing and gaining FDA approval (IVD 510k) for regulated medical devices. Deep understanding of the regulatory landscape for IVD products including FDA requirements and clinical trial processes; track record of supporting CAP/CLIA service development as well.
- Proven track record of successfully managing and scaling multiple simultaneous complex high-stakes programs with significant scientific and business impact.
- Strategic thinker with strong analytical and problem-solving abilities and the ability to balance long-term vision with short-term execution.
- Exceptional leadership communication and interpersonal skills with the ability to influence and collaborate effectively across all levels of the organization. Able to translate complex science and engineering topics for diverse audiences. Decisive proactive and composed with a balance of high IQ and EQ.
- 10 years of experience leading and managing teams exemplifying best practice in recruiting team-building employee performance management and career development goal-setting and cross-functional collaboration
Key Metrics
- Project Completion Rate: Percentage of projects completed on time within budget and to specifications.
- Budget Variance: Deviation between planned and actual project costs.
- Timeline Adherence: Percentage of projects meeting established deadlines and milestones.
- Regulatory Submission Success: Rate of successful regulatory submissions and approvals.
- Clinical Trial Milestones: Achievement of key clinical trial milestones and data readouts.
- Team Performance & Growth: Metrics related to team development retention and performance.
- Process Improvement Initiatives: Number and impact of implemented process improvements within the PMO.
$250000 - $300000 a year
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.
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.
This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.
Required Experience:
Exec
Employment Type
Full-Time
Key Skills
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