Position Summary
The Director, Project Management will support the cross-functional team in progressing drugs through each phase of the drug development pipeline. This individual will serve as the operational backbone of our development pipeline by integrating strategy, execution, and cross-functional alignment. In a resource-conscious startup environment, this role requires both strategic oversight and hands-on execution, ensuring our programs move forward with clarity and rigor.
The ideal candidate thrives in ambiguity, anticipates risks early, and brings structure to complex, rapid-moving initiatives. This leader will partner closely with Clinical, Nonclinical, CMC, Regulatory, Finance, and external CRO/CDMO partners to drive milestone delivery while maintaining capital efficiency. As Elion pursues non-dilutive government funding, including a potential BARDA award, this individual will also play a central role in supporting application efforts and, if successful, managing the ongoing obligations of a government-funded program.
Key Responsibilities
Program Leadership & Execution
· Own integrated development plans across preclinical and clinical programs, ensuring clear timelines, milestones, and deliverables
· Identify critical path risks early and develop mitigation strategies to achieve program timelines
· Translate scientific and regulatory strategy into actionable, trackable execution plans
· Partner with Regulatory to align development plans with global filing strategies
· Support Corporate Development activities as programs advance, including data room preparation, due diligence coordination, and partnership readiness
Governance & Communication
· Contribute to the development and quality review of key program documents, including clinical protocols, regulatory submissions, and clinical development plans
· Prepare concise, data-driven updates for leadership team and Board reporting
· Coordinate and facilitate program team meetings, ensuring focus on decisions, accountability, and next steps, establish agenda and provide meeting minutes
· Maintain clear documentation of risks, assumptions, and dependencies
· Act as point of contact for team information ensuring timely and effective communication of priority issues within the team and other relevant parties
Funding & Resource Stewardship
· Collaborate with Finance and functional leaders to develop and track program budgets
· Monitor burn against milestones and proactively identify resource gaps
· Support scenario planning to inform capital allocation decisions
· Support the preparation and submission of government grant applications, including BARDA, coordinating inputs from several functions
· Manage ongoing government program obligations, including milestone reporting, compliance deliverables, and technical reporting requirements, if a BARDA or similar award is secured
Qualifications
· 8+ years of experience in biotech/pharma, with significant project management responsibility across early and clinical-stage drug development
· Demonstrated success advancing programs in a cross-functional team environment within drug development through IND, Phase 1, and Phase 2
· Demonstrated project management skills that include analytical evaluation, organization, team management, negotiation, resource management skills, forecasting, and implementation
· Financial acumen and comfort managing budgets in capital-constrained settings
· Experience working with external CROs and CDMOs in a virtual biotech model
· Expertise with relevant project management software tools
· Personal and professional credibility as a leader to influence a highly intelligent and sophisticated audience, build consensus, and facilitate effective change
· Clear, executive-level communication skills.
· Comfortable operating in a lean, fast-paced, and highly-collaborative, small or emerging biotech startup environment
· Demonstrated ability to work independently and professionally while managing multiple responsibilities
· Bachelor’s degree in life sciences, business, or equivalent required
· Boston-based required
· PMP certification preferred
· Prior experience in venture-backed or early-stage biotech preferred
· Experience in anti-infectives or anti-fungal development preferred
· Experience supporting or managing a BARDA, NIH, or similar U.S. government-funded program preferred, including familiarity with federal reporting obligations and program officer relationships
