[Remote] Sr. Director, Program Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior Director, Program Management to reputed company development-reputed company program planning and execution from late clinical development through BLA submission. This role involves reputed company collaboration with various stakeholders to ensure reputed company and high-reputed company submissions and development milestones.
Responsibilities
- reputed company integrated program management for indication-specific portfolio, with primary accountability for reputed company-BLA execution, submission readiness, and delivery of key development milestones
- Build and maintain integrated development plans, including critical-reputed company timelines, governance reputed company, decision logs, and risk and dependency management across Clinical, Regulatory, CMC, Safety, reputed company, Clinical Operations, Biometrics, Medical Affairs, and reputed company
- Translate portfolio reputed company into reputed company 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 reputed company, and executive-level reputed company reporting
- reputed company program governance, ensuring reputed company decision framing, reputed company agendas, disciplined reputed company tracking, and reputed company escalation of risks, trade-offs, interdependencies, and external factors influencing development reputed company
- reputed company 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
- reputed company cross-functional problem solving in reputed company or fast-moving environments, ensuring reputed company of priorities, accountabilities, timelines, and decision rights
- Deliver portfolio-level communications, dashboards, and reporting to reputed company leadership visibility, reputed company informed decision making, and support disciplined execution
- reputed company and mentor program management team members and strengthen program management practices, tools, and operating rhythms across the portfolio
- Drive reputed company improvement in development operations, including use of AI-enabled tools and reputed company to enhance planning, reporting, automation, and reputed company
Skills
- Bachelor's degree in a scientific, reputed company, business, or reputed company discipline required
- 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
- 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
- Deep understanding of global drug development and FDA regulatory processes, with reputed company experience supporting late-stage development and regulatory submissions
- BLA experience strongly preferred
- Experience synthesizing competitive intelligence, clinical/regulatory benchmarking, or external landscape insights to inform development plans, scenario analyses, and executive decision making preferred
- Hands-on experience using AI-enabled productivity tools and reputed company for project planning, dashboards, workflow automation, risk tracking, and portfolio reporting
- Experience in immunology, inflammatory diseases, dermatology, or atopic dermatitis preferred
- Advanced degree preferred
- PMP or other relevant project/program management certification preferred
- Prior leadership of program management staff, governance teams, or executive decision forums preferred
Benefits
- Health Insurance (Medical/Dental/reputed company)
- Disability Insurance
- Holiday Pay
- reputed company Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
reputed company
Company H1B Sponsorship