About Us
About the Role
The Director, Clinical Project Management will have a significant impact in supporting across the clinical functions including clinical operations, regulatory, safety, and medical affairs teams and driving cross-functional communications.
You will be responsible for managing and tracking inter-disciplinary drug development programs performed by Dianthus personnel and strategic partners. This position will work closely with functional leadership to develop timelines to ensure effective delivery of milestones to achieve over-arching goals of the programs. Day to day, you will support project timelines, assist in facilitating meetings, maintain an overall program development timeline, communicate with our Director of CMC Program Management and develop strong internal cross-functional relationships to help ensure timely program deliverables. The ability to facilitate, obtain information required, synthesize important information to understand potential timeline risks, provide solutions, and be highly organized is critical for this role.
This is an exciting opportunity to join an early stage clinical team and have significant impact on our success. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.
Key Responsibilities
- Establish strong partnership with scientific leadership to shape help deliver objectives and work plan for assigned program(s)
- Develop and maintain an integrated 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 the critical points, and lead to increased understanding and optimized strategic planning & decision-making
- Support the standardization of processes and communication(s) in order to build efficiencies within the department and across R&D teams
- Proactively seek out opportunities for organizational improvement (e.g. team structure, processes, communication, etc.)
Experience
- Bachelor’s Degree required
- Experience working with Clinical Operations and other development teams as project or program manager
- 5+ years working as a Clinical Project Manager supporting all clinical functions including but not limited to Operations, Development, and regulatory
- Experience working with MS Project, MS Excel, CorasWorks (SharePoint Database or equivalent) and MS Word
- Understanding of clinical timelines and needs for milestone achievement and regulatory submissions
- Strong communication skills with ability to build professional relationships with external and internal stakeholders
- SAP experience or similar is preferred
- Attention to detail and accuracy with respect to internal and external reporting
- Strong business acumen
- PMP® certification preferred
- Strong understanding of US FDA and EU EMA regulations and ICH guidelines for biologic therapy products is preferred
