Sr. Manager or Associate Director, Program Management – Clinical, Medical & Regulatory

Scorpion Therapeutics; Missouri; On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced Program Management Senior Manager/Associate Director to align clinical programs with corporate goals. You will lead cross-functional study teams, develop scope, timelines, budgets, and dashboards, and drive governance across time zones.

You'll manage CROs and external partners, prepare regulatory filings support, and advance PMO best practices. Strong communication and Smartsheet mastery are essential in this fast-paced environment.

Qualifications

• 7+ years program management in biotech/cell & gene therapy clinical trials.
• Experience in pharmaceutical/biotechnology industries.
• Direct experience supporting regulatory Health Authority Inspections in a GxP environment.
• MS Office proficiency and familiarity with PM tools.
• Strong understanding of PMO operating models and scalable processes.
• Extensive Smartsheet experience (timelines, Gantt charts, dashboards, reporting).
• Vendor relationship/contract management experience.
• Strong verbal/written communication; attention to detail; multitasking.
• Ability to work independently and cross-functionally; thrive in fast-paced, timeline-based environments.

Responsibilities

• Align clinical program planning and execution with corporate objectives and PDT strategy.
• Develop project scope, timelines, budgets, and resource plans across the clinical portfolio.
• Lead cross-functional study teams and governance meetings (agendas, decision logs, minutes, action-item tracking).
• Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory to develop/maintain project plans, timelines, and dashboards.
• Maintain and communicate risks via risk registers with proactive mitigation and contingency plans; integrate risk trackers with corporate roadmaps.
• Manage CROs, vendors, and external partners (track performance/contracts, elevate issues, lead governance meetings).
• Support preparation and submission of regulatory filings (INDs, BLAs).
• Prepare and present project updates to senior leadership; partner with Finance and Legal to deliver on-time, on-budget milestones.
• Advance PMO best practices using tools/templates to enable continuous improvement.
• Serve as Smartsheet Super User (build/publish plans, dashboards, reports; train team).
• Work across time zones; travel 10–15%.

Skills

PM leadership

Cross-functional collaboration

Strong communication

Attention to detail

Multitasking

Independent work

Education

Advanced degree in Life Sciences

Tools

Smartsheet

MS Office

PM tools

Job description

Responsibilities

• Align clinical program planning and execution with corporate objectives and PDT strategy.
• Develop project scope, timelines, budgets, and resource plans across the clinical portfolio.
• Lead cross-functional study teams and governance meetings (agendas, decision logs, minutes, action-item tracking).
• Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory to develop/maintain project plans, timelines, and dashboards.
• Maintain and communicate risks via risk registers with proactive mitigation and contingency plans; integrate risk trackers with corporate roadmaps.
• Manage CROs, vendors, and external partners (track performance/contracts, elevate issues, lead governance meetings).
• Support preparation and submission of regulatory filings (INDs, BLAs).
• Prepare and present project updates to senior leadership; partner with Finance and Legal to deliver on-time, on-budget milestones.
• Advance PMO best practices using tools/templates to enable continuous improvement.
• Serve as Smartsheet Super User (build/publish plans, dashboards, reports; train team).
• Work across time zones; travel 10–15%.

Required Qualifications

• 7+ years (Sr. Manager) or 8+ years (Associate Director) program management in biotech/cell & gene therapy clinical trials.
• Experience in pharmaceutical/biotechnology industries.
• Direct experience supporting regulatory Health Authority Inspections in a GxP environment.
• MS Office proficiency and familiarity with PM tools.
• Strong understanding of PM best practices/PMO operating models and scalable processes.
• Extensive Smartsheet experience (timelines, Gantt charts, dashboards, reporting).
• Vendor relationship/contract management experience.
• Strong verbal/written communication; attention to detail; multitasking.
• Ability to work independently and cross-functionally; thrive in fast-paced, timeline-based environments.

Preferred Qualifications

• Advanced degree in Life Sciences.
• PMP/CAPM certification.
• Experience across early- and late-stage clinical programs.
• Cell & gene therapy/CAR-T (or similar) experience.