Job SummaryThe 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 ResponsibilitiesProgram 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
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$201,000-$239,000 USD
