Program Management Director - BLA
BLA Program Management
- Build, own and continuously maintain the integrated BLA master plan from pre-BLA meeting preparation through submission, filing, review, potential inspections, labeling negotiations and post-action commitments with external BLA regulatory consultants and dossier delivery team.
- Ensure all five CTD module plans are appropriately planned and integrated, including US regional content, summaries/overviews, CMC, nonclinical, clinical and labeling. Maintain the respective authoring, review, approval and publishing calendar as part of the overall BLA master plan.
Cross-functional Governance and Execution
- Establish and run the BLA Team, including meeting cadence, agendas, decision records and action logs.
- Prepare concise program updates for the CEO and Executive Committee, Board, and investors as appropriate.
Health Authority Meeting, inspection & response Readiness
- Establish and run the BLA Team, including meeting cadence, agendas, decision records and action logs.
- Prepare concise program updates for the CEO and Executive Committee, Board, and investors as appropriate.
- Coordinate operational preparation for Health Authority meetings, including briefing-book timelines, internal alignment, rehearsal, follow-up actions and agency-commitment tracking.
- Coordinate FDA pre-approval inspection readiness across internal teams, CMO, analytical laboratories, CROs and clinical sites.
- Establish and maintain the review "war room" for rapid, high-quality responses to FDA information requests.
The ideal candidate combines profound project management capabilities with hands-on leadership without authority skills and BLA delivery experience to deliver the right BLA-ready content, decisions, evidence, quality checks and inspection-readiness activities on time.
Experience
- Proven track record of successfully coordinating cross-functional teams and external CRO/CDMO/vendor networks in a small or mid-sized biotech environment.
- Structured, decisive and hands-on. Turns a complex biologics submission into a clear, accountable plan without creating unnecessary process.
- Proven ability to lead complex cross-functional teams without authority. Collaborative but firm. Protecting functional ownership while ensuring program-level decisions and timelines are me
- Executive ready communicator. Provides concise, decision-oriented reporting to the Executive Committee, Board and external partners.
Qualifications
- 10+ years in biotech/pharma program management, development operations, regulatory project management, or submission management
- BLA delivery experience from pre-submission through review and approval is strongly preferred.
- Strong familiarity with CTD design and submissions, FDA meeting preparation, information-request management, and inspection readiness a plus
- Strong Project Management skills
- Excellent written and spoken English required.
Permanent position