Director/Senior Director, Project Management

About Us

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

The experienced Director/Senior Director, Program Management have responsibilities for managing and tracking inter-disciplinary drug development programs performed by Dianthus personnel and strategic partners. This position will work closely with scientific leadership and subject matter experts on the program to develop, implement and manage program strategy, operations and processes to ensure alignment with corporate goals and timelines.

• We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

responsibilities for managing and tracking inter-disciplinary drug development programs performed by Dianthus personnel and strategic partners. This position will work closely with scientific leadership and subject matter experts on the program to develop, implement and manage program strategy, operations and processes to ensure alignment with corporate goals and timelines.

RESPONSIBILITIES

• Establish strong partnership with scientific leadership to shape the overall strategy, objectives and work plan for assigned program(s)
• Develop and maintain an integrated program plan (e.g., detailed Gannt, budget, resources, etc.) encompassing key program milestones and deliverables in alignment with program objectives
• Use meeting management best practices to drive cross-functional communication, timely and effective decision-making, and successful execution of program activities
• Proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams and functional leadership to develop and implement mitigation plans
• Lead the building of detailed program budgets with scientific staff and finance and partner with finance to keep program(s) on budget
• Build and maintain strong working relationships with scientific lead, internal departments and external partners to ensure the program remains on track
• Develop & deliver impactful presentations that effectively distill complex issues to critical points, and lead to increased understanding and optimized strategic planning & decision-making
• Support the standardization of processes and communication(s) to build efficiencies within the department and across R&D teams
• Proactively seeks out opportunities for organizational improvement (e.g. team structure, processes, communication, etc.)

Experience

• Bachelor’s Degree in any discipline required. Advanced degree (MS, PhD, or MBA) in Life Sciences preferred.
• 9+ years of Program Management experience in biomedical / Biopharma industry. Biologics or Antibody therapy is preferred.
• 8+ years of experience in clinical development and candidate selection, including translating biological systems through Phase 1–3 trials, assay validation, and IND/BLA filing preparations
• 3+ years of experience working with MS Project (Timeline Expert, Smart Sheets, etc.), MS Excel, Egnyte (SharePoint Database or equivalent), PowerPoint, and MS Word.
• Strong communication skills with ability to build professional relationships with external and internal stakeholders
• Attention to detail and accuracy with respect to internal and external reporting

Strong business acumen

PMP® certification preferred

• Strong understanding and experience with US FDA and EU EMA regulations and ICH guidelines for biologic therapy products is preferred

Originally posted on Himalayas