Senior Director, Program Management - Early Development

ROME Therapeutics is seeking an experienced Senior Director, Program Management, with a focus on Early Development - shaping and executing drug development strategies from Development Candidate declaration through clinical proof of concept - including IND-enabling, translational and early clinical studies. The position offers an exciting opportunity for a self-motivated and versatile individual familiar with multiple aspects of pre-clinical and early clinical development, including GMP scale-up, pre-clinical tox, translational studies, IND filings and clinical trial initiation. Responsibilities include providing program management support for ROME’s lead program and serving as a key member of the Program Core Team that is responsible for setting Program development strategy and ensuring flawless execution. The Early Development Program Manager is accountable for elements of the cross-functional planning and execution, including operational strategy, management of timelines, cost, quality, and risk assessment and mitigation. The individual will play an instrumental role in working cross functionally, across the entire organization, to organize and advance critical programs, and in enhancing overall program management capabilities at ROME.

What You’ll Do

• Partner with the Program Lead to formulate program strategy and drive/coordinate cross-functional planning and execution
• Serve as an integrator on the Program Core Team and across the organization to ensure alignment on implementation of program strategy
• Create and maintain a cross-functional short and long-term program development plan, with goals, timeline and budget for each program
• Ensure progress vs. plan, proactively identifying and facilitating team review of program risks and ensure mitigation plans are developed and implemented; work with the team to develop plans that enable parallel tracking when warranted
• Negotiate CRO and consulting agreements, with respect to pricing, payment schedules and other
• Develop and coordinate resource and budget planning across functions to assure adequate resources are applied to the project and any changes are highlighted appropriately
• Facilitate effective, science-based business decisions including development of scenarios as needed, highlighting interdependencies and downstream impacts (including but not limited to timelines and budget) of strategic decisions
• Ensure appropriate Program Core Team membership during the progression of the program
• Execute program management activities including setting meeting agendas that appropriately prioritize program needs, effectively documenting meetings with directive action items, and ensuring full communication of relevant information to maintain team alignment
• Communicate to team and stakeholders in a transparent and timely manner; engage with stakeholders at all levels of the organization to solicit input and feedback, incorporate learnings into team direction setting, problem resolution and lessons learned activities
• Develop and maintain a high performing operational approach including effective team building and conflict management; identify and manage situations requiring escalation
• As project management subject matter expert, understand best practices, identify gaps and challenges, implement efficiencies and improved ways of working
• Create a team environment that encourages cross-functional engagement, cooperation, accountability, and satisfaction

What You’ll Bring

• Advanced degree in Life Sciences, Chemical Sciences, Physical sciences or other relevant discipline, MS/Ph.D. preferred
• 12+ years of multidiscipline clinical experience at a biopharmaceutical company in areas of IND-enabling pre-clinical work, clinical trial planning, execution, and reporting and/or regulatory submissions with at least 2 years in a program management or similar role
• Demonstrated competency in early phase drug development with solid understanding of disease area and drug development pathways
• Proven track record, having supported at least 2 IND filings
• Demonstrated ability to drive cross-functional team success and achievement of timelines and goals in the context of a biopharmaceutical therapeutic development program
• Excellent project management skills – driving execution while balancing speed, quality, risk and cost, experience with Agile or Scrum process improvement strategies a plus
• Strong ability to identify short- and long-term program needs, manage and mitigate risk, creatively formulate plans with team input, achieve decisions/alignment and organize resources
• Experience resolving complex problems and managing difficult stakeholder situations
• Ability to lead the development of critical path analyses and scenario planning
• Strong communication skills, with ability to integrate and succinctly summarize, and effectively tailor messages to audience, including senior leaders
• Demonstration of self-awareness, understanding and acknowledgement of own strengths and limitations and respect for others’ preferences and expertise
• Ability to handle complexity, prioritize and multi-task program demands
• Proficiency in Microsoft Outlook, Word, Excel, PowerPoint, GANTT chart software (MS Project, SmartSheet or similar tool)
• Experience in autoimmune disease and/or oncology (strongly preferred)
• Knowledge of global regulatory guidelines (preferred)
• Demonstrated success working across internal and external teams (CROs, academic collaborators, etc.), an established network of CROS and consultants is a plus
• Willingness to work in a hybrid (in-person/remote) work environment as needed
• Vaccination against COVID-19 is mandatory, subject to medical and religious accommodations, and proof of vaccination must be provided to ROME
• This role can be remote, hybrid or onsite