At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.
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
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:
Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.