Senior Director, Program Management
11650 - Sr Director, Program Management | Final Job Description
Summary
The Senior Director, Program Management will lead development-side program planning and execution from late clinical development through BLA submission. This role partners closely with Clinical Development, Regulatory, Clinical Operations, Biostatistics, Safety, CMC, and executive stakeholders to translate strategy into integrated plans, decision-ready governance, and disciplined execution. The role drives cross-functional alignment, scenario planning, risk management, resource planning, competitive intelligence benchmarking, and portfolio-level transparency to enable timely, high-quality submissions, development milestones, and evidence-informed decision making.
Essential Duties and Responsibilities
- Lead integrated program management for indication-specific portfolio, with primary accountability for pre-BLA execution, submission readiness, and delivery of key development milestones.
- Build and maintain integrated development plans, including critical-path timelines, governance cadence, decision logs, and risk and dependency management across Clinical, Regulatory, CMC, Safety, Quality, Clinical Operations, Biometrics, Medical Affairs, and Commercial.
- Translate portfolio strategy into clear objectives, milestones, resourcing assumptions, and executable cross-functional workplans in partnership with development leadership.
- Drive BLA-readiness planning, including coordination of submission workstreams, cross-functional deliverables, scenario planning, issue resolution, and executive-level progress reporting.
- Lead program governance, ensuring clear decision framing, aligned agendas, disciplined action tracking, and timely escalation of risks, trade-offs, interdependencies, and external factors influencing development strategy.
- Integrate competitive intelligence benchmarking into program planning and governance by synthesizing relevant external development and regulatory insights to inform scenario planning, risk assessment, and leadership recommendations.
- Lead cross-functional problem solving in complex or fast-moving environments, ensuring clarity of priorities, accountabilities, timelines, and decision rights.
- Deliver portfolio-level communications, dashboards, and reporting to provide leadership visibility, enable informed decision making, and support disciplined execution.
- Coach and mentor program management team members and strengthen program management practices, tools, and operating rhythms across the portfolio.
- Drive continuous improvement in development operations, including use of AI-enabled tools and Smartsheet to enhance planning, reporting, automation, and knowledge management.
Additional Qualifications
- Deep understanding of global drug development and FDA regulatory processes, with direct experience supporting late-stage development and regulatory submissions; BLA experience strongly preferred.
- Demonstrated success leading complex, cross-functional pharmaceutical or biotechnology programs in matrixed environments.
- Executive presence and communication skills, with ability to synthesize complex information into clear, decision-ready recommendations.
- Proven ability to manage program risks, dependencies, budgets, external partners, and competing priorities while maintaining delivery discipline.
- Excellent analytical, planning, facilitation, and problem-solving skills.
- Experience synthesizing competitive intelligence, clinical/regulatory benchmarking, or external landscape insights to inform development plans, scenario analyses, and executive decision making preferred.
- Proficiency with Microsoft Office and modern project/portfolio management tools.
- Preferred: hands-on experience using AI-enabled productivity tools and Smartsheet for project planning, dashboards, workflow automation, risk tracking, and portfolio reporting.
- Experience in immunology, inflammatory diseases, dermatology, or atopic dermatitis preferred.
Education or Degree Requirements
Bachelor's degree in a scientific, healthcare, business, or related discipline required; advanced degree preferred. PMP or other relevant project/program management certification preferred. Equivalent experience may be considered.
Minimum Professional Experience
Typically requires 15+ years of relevant pharmaceutical, biotechnology, or life sciences experience, including significant experience leading cross-functional drug development programs. Late-stage development and regulatory submission experience required; BLA submission experience strongly preferred. Prior leadership of program management staff, governance teams, or executive decision forums preferred.
Physical Requirements
Primarily remote-based role with standard physical requirements. Travel may be required for business meetings, partner interactions, and regulatory/submission-related activities.