Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
6 Years
Description
- Collaborate with Program Leaders, Lead Program Managers, and cross-functional leaders to drive integrated program strategy and execution across assigned programs that may span multiple products, indications, development stages, and therapeutic areas, including infectious disease, rare disease, oncology, and immunology. Depending on program stage and assignment, your responsibilities may extend from early development and pivotal readiness through filing, approval, launch preparation, and post-approval lifecycle planning and management.
- Lead the development and maintenance of integrated program plans that connect Research, CMC, Development, Medical Affairs, Commercial, and other relevant enabling functions. Bring together key activities, dependencies, timelines, milestones, critical paths, and decision points to support coordinated decision-making, integrated planning, and successful program progression.
- Drive cross-functional alignment by proactively identifying and managing risks, issues, and interdependencies. Coordinate mitigation, escalation, and resolution so teams understand how decisions and changes affect program priorities, development plans, and execution.
- Lead or support preparation for key stage-gate, regulatory, filing, approval, launch-readiness, and governance decisions, based on program stage and assignment. Ensure program materials clearly communicate progress, dependencies, risks, and decisions requiring leadership input.
- Facilitate effective program team meetings and working sessions, ensuring clear decisions, ownership, accountability, and follow-through. Translate cross-functional discussions into coordinated actions and ensure execution against critical program milestones.
- Integrate Medical Affairs and Commercial priorities into program planning, including evidence generation, medical and commercial readiness, launch planning, and lifecycle activities, as appropriate to program stage. Maintain alignment between these priorities, development plans, regulatory strategy, and overall program objectives.
- Develop scenario analyses, recommendations, and program materials to support strategic and operational decision-making. Help teams evaluate options, understand trade-offs, and determine how alternative approaches affect timelines, dependencies, and execution priorities.
- Monitor program progress against key milestones, budgets, and objectives. Provide clear visibility into program performance and areas requiring leadership attention, supporting timely decisions and appropriate course corrections.
- Lead assigned programs, indications, workstreams, or cross-functional initiatives with an appropriate level of independence. Balance multiple programs or priorities in parallel while contributing to broader Program Management capabilities and best practices.
- Explore opportunities to use generative AI tools to support information synthesis, integrated planning, and program communications, where appropriate, with human review and safeguards for confidential information.
Qualifications
Highest qualification: University
- BS degree in a scientific field with a minimum of 6 years of experience or MS degree in a scientific field at least 4 years of experience in a biotechnology or pharmaceutical setting.
- Proven track record of successful project management experience in drug development across multiple phases (pre-clinical and clinical Phase 1-3).
- Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility.
- Strong knowledge of project management tools and software (e.g., Smartsheet, MS Project, and timeline visualization software).
- Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
- Strong personal skills to influence without authority, motivate others and manage conflict.
- Strong written and oral communication skills as well as demonstrated organizational aptitude.
Project/program management training. - Ph.D. or PharmD and 2+ years of experience in a biotechnology or pharmaceutical setting.
- Experience leading or coordinating regulatory filings.
- Laboratory experience in an academic or biotechnology setting.
