DotLab is a personalized medicine company focused on women's health and is starting with the development of a cutting-edge molecular diagnostic test for endometriosis. Ten percent of women of child-bearing age suffer from this debilitating disease, which takes an average of a decade to diagnose. We're looking to change that.
DotLab is hiring a Project Manager to work with our team on reimagining the experience of physicians and patients in women's health. While much of today's approach to endometriosis is marred by complexity and misinformation, we're looking for someone who is excited to significantly improve the patient and physician journeys and make a lasting impact in women's health.
- Develop project scopes and objectives through effective collaboration with key stakeholders across R&D, Regulatory, Clinical/Medical, and Commercial.
- Provide project management expertise and support to DotLab projects, such as product development and operations/scalability, to ensure all milestones and deliverables are met and activities are well executed and managed.
- Oversee timely delivery of projects, ensuring they remain within scope and within budget.
- Organize and coordinate internal resources and third parties/vendors for the flawless execution of projects.
- Analyze and manage risks, minimizing negative effects on a project, while communicating issues & outcomes to relevant stakeholders and team leadership.
- Monitor project performance with the help of appropriate systems, tools, and techniques, and manage changes in project scope, schedule and costs with the help of appropriate verification techniques.
- Schedule, organize, and drive project team meeting(s): prepare and distribute agendas/minutes; track action items, and escalate areas of concern to the appropriate management entity.
- Manage the interfaces between functional areas and ensure effective handoff and communication between department functions to execute on important project milestones.
- Works with project lead and/or SME to prepare status reports, specific project updates, or scenarios as needed.
- Optimize teams' effectiveness and decision making, facilitate team building and communication.
- Prepare and review comprehensive project documentation.
- Manage document review practice to support submission activities and other key project deliverables.
- Minimum BA/BS in a scientific discipline, while an advanced degree (PhD, MS, MBA, MD) in a discipline related to healthcare, life sciences, drug development or business is desirable.
- 5 years multidisciplinary experience in the biotech/pharmaceutical industry required, with preference for 1-3 years direct project management in diagnostics development.
- Understanding of CLIA/CAP, FDA regulatory processes and prior experience with regulatory filings with Device/Diagnostics.
- Project Management Certification (PMP or equivalent) and familiarity with developing budgets and forecasting is preferred.
- Ability to drive project plans and timelines (across multiple functional areas) is essential.
- Proven ability to proactively identify risks and drive resolution of issues.
- Excellent organizational skills.
- Results- and detail-oriented with strong analytical and problem solving capabilities.
- Self-motivated, ability to work with minimal supervision in a fast-paced environment under tight deadlines.
- Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
- Strong communication skills (in person and written word) and ability to interact with a diverse group of individuals.
- Demonstrated ability to develop, manage, and lead cross-functional teams.