Director, Program Management

Job Summary

The Director, Program Management, will provide strategic and operational leadership for the rinvatercept (KER-065) development program. This individual will lead cross-functional program planning and execution as rinvatercept advances through clinical development.  The ideal candidate will combine strong drug-development program leadership with meaningful experience running clinical trials across Phase 1, Phase 2 and Phase 3.

The successful candidate will move effectively between strategic planning and hands-on execution, anticipate and mitigate risks, drive timely decisions and maintain alignment across Clinical Development, Clinical Operations, Regulatory Affairs, CMC/Technical Operations, Nonclinical, Biometrics and other functions.

Primary Responsibilities

Program Strategy and Leadership

• Serve as the program management lead for rinvatercept, partnering with functional leaders to define and execute the optimal global development strategy
• Lead the cross-functional program team, including representatives from Clinical Development, Clinical Operations, Regulatory Affairs, CMC/Technical Operations, Nonclinical, Biometrics, Medical Affairs, Commercial and Corporate Strategy
• Guide the program through proof of concept, registration-enabling studies, regulatory submissions and potential marketing authorization
• Translate development strategy into clear program objectives, operational priorities and measurable deliverables
• Mobilize and align the organization around the program strategy and drive timely decision-making through appropriate governance forums
• Balance day-to-day program execution with long-range strategic planning

Integrated Development Planning

• Create and maintain an integrated strategic development plan covering program goals, value-creation milestones, critical-path activities, cross-functional dependencies, timelines, decision points, assumptions, risks, alternative scenarios, budget and resource requirements
• Ensure functional plans are aligned with the overall development strategy and that interdependencies are clearly understood and actively managed
• Identify potential gaps, conflicts and constraints before they affect clinical, regulatory or operational milestones
• Lead scenario planning to evaluate alternative development approaches and their implications for timeline, resources, risk and program value

Clinical Development and Trial Execution

• Partner with Clinical Development and Clinical Operations to plan and execute rinvatercept clinical trials across Phase 1, Phase 2 and Phase 3
• Integrate clinical activities with regulatory, CMC, nonclinical, biometrics and other program workstreams
• Identify and manage dependencies affecting protocol development, regulatory submissions, site activation, patient enrollment, study conduct, data delivery and clinical readouts
• Support transitions between stages of development, including progression from early clinical studies into proof-of-concept and registration-enabling trials
• Apply an understanding of neuromuscular and rare-disease trial challenges, including specialized investigator sites, patient recruitment, natural-history considerations, endpoints and global execution
• Ensure clinical-trial plans are supported by realistic timelines, budgets, resources and risk-mitigation plans

Cross-Functional Team Effectiveness

• Establish and lead an effective operating cadence for program team meetings, working sessions and governance reviews
• Prepare agendas, facilitate discussions and ensure decisions, action items, owners and deadlines are clearly documented and communicated
• Foster strong relationships with program team members and functional line leaders, and serve as a central point of contact for program communications and issue resolution
• Create clarity around roles, responsibilities and decision rights to enable efficient execution and accountability
• Promote a program culture characterized by urgency, transparency, scientific rigor, collaboration and respect

Governance and Decision-Making

• Represent the rinvatercept program team at internal governance meetings, in collaboration with relevant team members
• Develop high-quality program updates, recommendations and decision materials for senior management and governance committees
• Present program strategy, operating plans, progress, risks and alternative scenarios clearly and persuasively
• Ensure governance decisions are documented and translated into executable cross-functional plans
• Proactively escalate issues requiring senior-management attention and provide clear options and recommendations
• Maintain a decision log capturing major decisions, assumptions, rationale and implications

Risk, Issue and Dependency Management

• Establish and maintain an integrated risk register covering clinical, regulatory, CMC, nonclinical, operational, financial and strategic risks
• Work with functional leaders to define mitigation plans, contingency actions, owners and escalation thresholds
• Proactively identify emerging issues that could affect program timelines, clinical execution, regulatory strategy or key value-creation milestones
• Facilitate timely resolution of cross-functional issues and ensure agreed mitigation actions are completed

Executive and External Communication

• Communicate program strategy, operating plans, progress and risks effectively to senior management
• Represent the program team in scientific and business discussions, conveying complex information concisely and in a decision-oriented manner
• As appropriate, represent rinvatercept and Keros in interactions with investigators, scientific experts, development partners, patient-advocacy organizations and other external stakeholders
• Partner with Clinical Development, Medical Affairs and other functions to incorporate relevant external perspectives into program planning

Program Operations, Budget and Resources

• Coordinate program budgets, forecasts and resource assumptions with Finance and functional leaders
• Monitor execution against approved timelines, budgets and resource plans
• Identify resource constraints and capacity risks early and work with functional leadership to develop practical solutions
• Support vendor and external-partner planning where activities span multiple program functions
• Establish and continuously improve fit-for-purpose program-management processes, tools, reporting practices and documentation

Core Competencies (Required Skills)

• At least 10 years of biotechnology or pharmaceutical drug-development experience, including substantial experience in clinical-stage development
• At least 5 years in program management, program leadership, clinical operations or a closely related cross-functional development role
• Demonstrated experience supporting or leading clinical programs across Phase 1, Phase 2 and Phase 3
• Strong understanding of end-to-end drug development and the interdependencies among clinical, regulatory, CMC, biometrics, nonclinical and commercial activities
• Demonstrated ability to lead complex cross-functional teams and influence at all levels of an organization
• Experience applying program-management principles and practices to integrated development plans, timelines, dependencies, risks, decisions, budgets and resources
• Must be located in the Boston area or willing to relocate and able to work from the office four days per week
• Ability to travel up to 10%, including domestic and international travel

Preferred Skills

• Strong analytical and problem-solving skills, combining attention to detail with a broad strategic perspective
• Ability to thrive in a fast-paced biotechnology environment that requires both strategic leadership and hands-on execution
• Excellent written and oral communication, presentation and facilitation skills, with the ability to be persuasive in scientific and business forums

Education Requirements

• Bachelor's degree in a scientific, medical, engineering or related discipline; advanced degree preferred

Potential base pay range 201000 - 239000 USD