Director, Program Management

Keros Therapeutics • Lexington, MA

1d • $201,000 - $239,000 • Hybrid

About The Position

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, combining drug-development program leadership with experience running clinical trials across Phase 1, Phase 2 and Phase 3.

The role requires moving between strategic planning and hands-on execution, anticipating and mitigating risks, driving timely decisions, and maintaining alignment across Clinical Development, Clinical Operations, Regulatory Affairs, CMC/Technical Operations, Nonclinical, Biometrics and other functions. The Director will guide the program through proof of concept, registration-enabling studies, regulatory submissions and potential marketing authorization; create and maintain integrated development plans; and coordinate program governance, risk management, communications, budgets and resources.

The position requires the employee to be located in the Boston area or willing to relocate and able to work from the office four days per week. Travel of up to 10%, including domestic and international travel, may be required.

Requirements

• 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 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.
• Bachelor's degree in a scientific, medical, engineering or related discipline.

Nice To Haves

• Advanced degree.
• Strong analytical and problem-solving skills, combining attention to detail with a broad strategic perspective.
• Ability to thrive in a fast-paced biotechnology environment requiring 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.

Responsibilities

• Serve as the program management lead for rinvatercept and partner with functional leaders to define and execute the 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 program objectives, operational priorities and measurable deliverables, and drive timely decisions through governance forums.
• Create and maintain an integrated strategic development plan covering goals, milestones, critical-path activities, dependencies, timelines, decision points, assumptions, risks, scenarios, budgets and resource requirements.
• Align functional plans with the overall development strategy, manage interdependencies, and identify gaps, conflicts and constraints before they affect milestones.
• Lead scenario planning to evaluate alternative development approaches and their implications for timelines, resources, risk and program value.
• Partner with Clinical Development and Clinical Operations to plan and execute Phase 1, Phase 2 and Phase 3 clinical trials.
• Integrate clinical activities with regulatory, CMC, nonclinical, biometrics and other program workstreams.
• 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 to proof-of-concept and registration-enabling trials.
• Apply 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 have realistic timelines, budgets, resources and risk-mitigation plans.
• Establish and lead program-team meeting, working-session and governance-review cadences; facilitate discussions and document decisions, actions, owners and deadlines.
• Foster relationships with program team members and functional leaders, serve as a central point of contact for program communications and issue resolution, and clarify roles, responsibilities and decision rights.
• Promote a program culture of urgency, transparency, scientific rigor, collaboration and respect.
• Represent the program team at internal governance meetings and develop program updates, recommendations and decision materials for senior management and governance committees.
• Present program strategy, operating plans, progress, risks and alternative scenarios clearly; document governance decisions and translate them into executable plans.
• Escalate issues requiring senior-management attention and provide options and recommendations; maintain a decision log of major decisions, assumptions, rationale and implications.
• Establish and maintain an integrated risk register covering clinical, regulatory, CMC, nonclinical, operational, financial and strategic risks.
• Work with functional leaders to define risk mitigations, contingency actions, owners and escalation thresholds; facilitate resolution of cross-functional issues.
• Communicate program strategy, operating plans, progress and risks to senior management and represent the program in scientific and business discussions.
• As appropriate, represent rinvatercept and Keros in discussions with investigators, scientific experts, development partners, patient-advocacy organizations and other external stakeholders.
• Partner with Clinical Development, Medical Affairs and other functions to incorporate external perspectives into program planning.
• Coordinate program budgets, forecasts and resource assumptions with Finance and functional leaders, and monitor execution against approved plans.
• Identify resource constraints and capacity risks early and work with functional leadership on practical solutions.
• Support vendor and external-partner planning for activities spanning multiple program functions.
• Establish and continuously improve fit-for-purpose program-management processes, tools, reporting practices and documentation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director