Associate Director/Director, Clinical Program Management

Liquidia Technologies; United States; In loco; USD 180.000 - 280.000; Tempo pieno

Descrizione del lavoro

Liquidia Technologies seeks a Director/Assoc. Director of Program Management to lead cross-functional planning and execution for pulmonary hypertension programs. You will co-lead with stakeholders across Operations, Development, Regulatory, Medical Affairs and Commercial to deliver inhaled therapies from concept to commercialization.

The role requires 8+ years in matrix management, and preferably an advanced degree. Experience with IND to NDA/BLA and global launches is essential.

Competenze

• Bachelor’s degree with 8+ years in matrix management.
• Experience from IND to NDA/BLA and global launch.
• Biopharma/biotech industry background required.
• Experience with Phase 4 studies preferred.
• Strong cross-functional interdependencies knowledge.

Mansioni

• Lead cross-functional planning, execution, and delivery of trials.
• Co-lead with internal and external stakeholders.
• Manage timelines, critical paths, and dependencies.
• Oversee budget and vendor oversight for timelines.
• Develop mitigation plans for program risks.
• Ensure regulatory readiness across modalities.

Conoscenze

Cross-functional leadership

Strategic direction

Excellent communication

Negotiation skills

Forecasting and budgeting

Risk management

Decision making

Project/program management

Stakeholder management

Smartsheet proficiency

PMP or equivalent training

Formazione

Bachelor’s degree and 8+ years experience

Advanced degree (MS, PhD, MBA) preferred

Strumenti

Smartsheet

Descrizione del lavoro

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Director/Assoc. Director of Program Management will have a cross-functional role in the planning, execution, and delivery of clinical trials, initially focusing on our L606 and Yutrepia programs. You will co-lead and work closely with internal and external stakeholders to bring transformative therapies to market innovative inhaled combination products. The successful candidate will have strong product life cycle management experience, preferably in pulmonary hypertension (or related therapeutic areas), understanding key elements of product and study conceptualization through to commercialization. Engaging, building, and maintaining excellent working relationships with functional leaders across Operations, Product Development, Clinical Operations, Regulatory, Medical Affairs and Commercial, along with external partners, will be essential for this role. Strong relationships with vendors with critical oversight to help development and budgetary timelines is essential for this role.

Education/Experience:

• Bachelor’s degree and a minimum of 8 years of relevant experience with a focus on matrix management. Advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline.
• Experience with program management from IND to NDA/BLA and global launch including a solid understanding of global registration processes. Experience with Phase 4 studies is also preferred.
• Experience in biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory).
• Experience managing integrated timelines, critical paths, resource constraints, and dependencies across concurrent development programs.

Knowledge Skills and Abilities:

• Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
• Excellent communication, negotiation, problem solving and decision-making abilities.
• Ability to develop forecasts, assess resource variances, and communicate risks.
• Ability to establish decision logs, ownership, escalation pathways, and follow-through across matrix teams.
• Demonstrated ability to identify critical program risks and develop mitigation plans
• Experience supporting combination device programs, inhaled technologies and/or small molecules is strongly preferred.
• Proven experience managing complexity in global programs across multiple modalities.
• Proficiency with project management and reporting tools, such as Smartsheet.
• PMP or equivalent project / program management training is preferred.

• Develop and implement cross-functional development plans at both a strategic and tactical level. Understand functional interfaces and drive cross-functional alignment to achieve corporate milestones.
• Escalate risk effectively to senior management, while also developing and implementing mitigation strategies.
• Experience with planning ‘with the end in mind’, so that commercial viability of development programs are adequately assessed throughout the product life cycle.
• Facilitate regular team and cross-functional meetings, develop dashboards, and provide status updates to senior management.
• Assist with the budgeting process, tracking study and operational budgets to ensure efficient allocation of resources across projects.
• Monitor evolving regulatory requirements and quality trends across modalities to ensure readiness and proactive compliance planning.