Liquidia Corporation
Director, Clinical Program Management
Liquidia Corporation, Morrisville, North Carolina, United States, 27560
Job Summary
The Director/Senior Director of Clinical Program Management will work closely with multiple functional leads in the planning, execution, and delivery of key assets, initially focusing on Liquidia’s L606 and Yutrepia programs. This role will provide strategic leadership and steer internal and external stakeholders to a common goal, playing a large role in bringing transformative therapies to market.
The successful candidate will have extensive product life cycle management experience, preferably in pulmonary hypertension (or related therapeutic areas), understanding key elements of product and study conceptualization through 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, is a critical success factor. The ability to maintain a 6 to 12 month ‘big picture’ view to thereby quickly escalating corporate risk is essential for this role.
Responsibilities
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.
Ability to consistently think of the bigger picture, so that commercial viability of development programs is 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 as well as key milestones of competitors to ensure proactive planning.
Requirements Education and Experience
Bachelor’s degree and a minimum of 12 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 supporting combination device programs, inhaled technologies and/or small molecules is strongly preferred.
Experience with PAH, IPF, or other rare diseases is highly preferred.
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.
Demonstrated ability to identify critical program risks and develop mitigation plans – strategic or tactical to mitigate risk, and costs.
Demonstrated technical experience and success supporting clinical‑to‑commercial transitions in small molecule and inhaled combination products.
Proven experience managing complexity in global programs across multiple modalities.
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note: Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
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The successful candidate will have extensive product life cycle management experience, preferably in pulmonary hypertension (or related therapeutic areas), understanding key elements of product and study conceptualization through 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, is a critical success factor. The ability to maintain a 6 to 12 month ‘big picture’ view to thereby quickly escalating corporate risk is essential for this role.
Responsibilities
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.
Ability to consistently think of the bigger picture, so that commercial viability of development programs is 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 as well as key milestones of competitors to ensure proactive planning.
Requirements Education and Experience
Bachelor’s degree and a minimum of 12 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 supporting combination device programs, inhaled technologies and/or small molecules is strongly preferred.
Experience with PAH, IPF, or other rare diseases is highly preferred.
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.
Demonstrated ability to identify critical program risks and develop mitigation plans – strategic or tactical to mitigate risk, and costs.
Demonstrated technical experience and success supporting clinical‑to‑commercial transitions in small molecule and inhaled combination products.
Proven experience managing complexity in global programs across multiple modalities.
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note: Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
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