Senior Director, Drug Development Program Management (Head of Program Management
Orphai Therapeutics, New York, NY, United States
Senior Director, Drug Development Program Management (Head of Program Management)
Company Description
Orphai Therapeutics is dedicated to discovering and developing transformative therapies for patients with serious, underserved diseases. Our lead programs are advancing toward the clinic in pulmonary hypertension and bronchiolitis obliterans syndrome in post-lung transplant patients. We combine scientific rigor with a technology-enabled approach to accelerate development and improve patient outcomes.
Joining Orphai Therapeutics is an opportunity to help build and scale a drug development organization from the ground up—pairing strong execution with the urgency and mission focus of a company working to change patients’ lives.
Role Description Orphai Therapeutics is seeking a senior, highly independent leader to build and lead Drug Development Program Management. This role is accountable for end-to-end program execution across discovery through clinical development and early commercialization readiness—driving integrated plans, timelines, budgets, governance, and cross-functional decision-making. The Head of Program Management will establish fit-for-purpose systems and operating rhythms, anticipate and mitigate risks, and ensure programs deliver on strategic objectives with clear accountability.
As part of our team, your core responsibilities will be to:
Build, lead, and scale the Program Management function, serving as the operational owner of integrated execution across the portfolio.
Drive creation and maintenance of Integrated Development Plans (IDPs) spanning discovery, CMC, nonclinical, clinical, regulatory, biometrics, quality, pharmacovigilance, and external partners; ensure clear critical path, dependencies, and resourcing assumptions.
Own program and portfolio timelines and operating plans; define milestones, stage gates, and success criteria; proactively identify schedule risks and develop options to recover timelines.
Lead cross-functional core teams and working groups; ensure meeting discipline, crisp agendas, effective facilitation, and documented outcomes with accountable owners and due dates.
Partner with Functional Leads to plan, track, and optimize program budgets and resources; support scenario planning and trade-off recommendations aligned to strategy and cash runway.
Drive risk management and issue resolution by implementing and maintaining RAID processes; elevate early with recommended paths forward and clear impacts to scope, timing, and cost.
Implement standardized metrics and reporting to enable transparency and accountability across the organization; continuously improve the operating model as the company scales.
Ensure high-quality execution across major drug development deliverables, including key CMC/nonclinical/clinical/regulatory plans, submissions, and study start-up/close-out readiness.
Build a culture of ownership, urgency, and collaboration; coach and develop team members as future PM headcount is added.
Qualifications
10+ years of progressive drug development program/project management experience in biotech/pharma, including leading cross-functional development teams.
Demonstrated ownership of integrated development plans, critical paths, and portfolio/program budgets, with strong decision support and scenario planning skills.
Proven ability to lead through influence by aligning senior functional leaders and external partners, driving accountability, and resolving conflict to enable execution.
Track record of building or scaling PM processes/operating rhythms (governance, templates, reporting, RAID management) in a fast-moving, resource-constrained environment.
Strong operational excellence mindset with demonstrated continuous improvement by simplifying workflows, clarifying RACI/ownership, and improving speed and quality of execution.
Excellent written and verbal communication skills, including the ability to create decision-ready materials for executives and the Board.
Proficiency with modern planning and reporting tools (e.g., Smartsheet, MS Project, Excel/PowerPoint) and strong data discipline for status/metrics.
Bachelor’s degree required (advanced degree preferred) in a scientific, engineering, or related discipline; equivalent experience considered.
Experience in biotech/pharma drug development required; rare disease and/or cardiopulmonary/respiratory experience is a plus.
Additional Information We offer great perks:
Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great value on our teams’ well-being
Competitive salaried compensation - we value our employees and show it
Equity - we want every employee to be a stakeholder
401k plan - we facilitate your retirement goals
Remote work – because family life is important
The opportunity to develop a revolutionary healthcare products and save millions of lives!
For this role, we provide visa assistance for qualified candidates.
Orphai Therapeutics does not accept agency resumes.
Orphai Therapeutics is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.
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Joining Orphai Therapeutics is an opportunity to help build and scale a drug development organization from the ground up—pairing strong execution with the urgency and mission focus of a company working to change patients’ lives.
Role Description Orphai Therapeutics is seeking a senior, highly independent leader to build and lead Drug Development Program Management. This role is accountable for end-to-end program execution across discovery through clinical development and early commercialization readiness—driving integrated plans, timelines, budgets, governance, and cross-functional decision-making. The Head of Program Management will establish fit-for-purpose systems and operating rhythms, anticipate and mitigate risks, and ensure programs deliver on strategic objectives with clear accountability.
As part of our team, your core responsibilities will be to:
Build, lead, and scale the Program Management function, serving as the operational owner of integrated execution across the portfolio.
Drive creation and maintenance of Integrated Development Plans (IDPs) spanning discovery, CMC, nonclinical, clinical, regulatory, biometrics, quality, pharmacovigilance, and external partners; ensure clear critical path, dependencies, and resourcing assumptions.
Own program and portfolio timelines and operating plans; define milestones, stage gates, and success criteria; proactively identify schedule risks and develop options to recover timelines.
Lead cross-functional core teams and working groups; ensure meeting discipline, crisp agendas, effective facilitation, and documented outcomes with accountable owners and due dates.
Partner with Functional Leads to plan, track, and optimize program budgets and resources; support scenario planning and trade-off recommendations aligned to strategy and cash runway.
Drive risk management and issue resolution by implementing and maintaining RAID processes; elevate early with recommended paths forward and clear impacts to scope, timing, and cost.
Implement standardized metrics and reporting to enable transparency and accountability across the organization; continuously improve the operating model as the company scales.
Ensure high-quality execution across major drug development deliverables, including key CMC/nonclinical/clinical/regulatory plans, submissions, and study start-up/close-out readiness.
Build a culture of ownership, urgency, and collaboration; coach and develop team members as future PM headcount is added.
Qualifications
10+ years of progressive drug development program/project management experience in biotech/pharma, including leading cross-functional development teams.
Demonstrated ownership of integrated development plans, critical paths, and portfolio/program budgets, with strong decision support and scenario planning skills.
Proven ability to lead through influence by aligning senior functional leaders and external partners, driving accountability, and resolving conflict to enable execution.
Track record of building or scaling PM processes/operating rhythms (governance, templates, reporting, RAID management) in a fast-moving, resource-constrained environment.
Strong operational excellence mindset with demonstrated continuous improvement by simplifying workflows, clarifying RACI/ownership, and improving speed and quality of execution.
Excellent written and verbal communication skills, including the ability to create decision-ready materials for executives and the Board.
Proficiency with modern planning and reporting tools (e.g., Smartsheet, MS Project, Excel/PowerPoint) and strong data discipline for status/metrics.
Bachelor’s degree required (advanced degree preferred) in a scientific, engineering, or related discipline; equivalent experience considered.
Experience in biotech/pharma drug development required; rare disease and/or cardiopulmonary/respiratory experience is a plus.
Additional Information We offer great perks:
Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great value on our teams’ well-being
Competitive salaried compensation - we value our employees and show it
Equity - we want every employee to be a stakeholder
401k plan - we facilitate your retirement goals
Remote work – because family life is important
The opportunity to develop a revolutionary healthcare products and save millions of lives!
For this role, we provide visa assistance for qualified candidates.
Orphai Therapeutics does not accept agency resumes.
Orphai Therapeutics is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr