Associate Director/Director, Clinical Program Management

Posted Yesterday
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Hiring Remotely in USA
Remote
Senior level
Biotech • Pharmaceutical
The Role
Leads cross-functional planning, execution, and delivery of clinical development programs from IND through NDA/BLA and global launch. Coordinates Clinical Operations, Regulatory, Medical Affairs, Commercial, Product Development, vendors, and other stakeholders. Manages integrated timelines, budgets, resources, risks, dependencies, dashboards, and mitigation plans while ensuring regulatory and quality readiness for inhaled combination therapies.
Summary Generated by Built In
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. 
Job requirements
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. 

Job 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.
  • 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.

Benefits
Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, 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.

Skills Required

  • Bachelor's degree
  • At least 8 years of relevant experience focused on matrix management
  • Program management experience from IND through NDA/BLA and global launch
  • Experience in the biotechnology or pharmaceutical industry
  • Experience managing integrated timelines, critical paths, resource constraints, and dependencies across concurrent development programs
  • Understanding of cross-functional interdependencies across R&D, commercial, technical development, and regulatory functions
  • Experience managing complexity in global programs across multiple modalities
  • Proficiency with project management and reporting tools such as Smartsheet
  • Advanced degree such as MS, PhD, or MBA in a relevant biopharmaceutical discipline
  • Experience with Phase 4 studies
  • Experience supporting combination device programs, inhaled technologies, or small molecules
  • PMP certification or equivalent project or program management training
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The Company
HQ: Morrisville, NC
216 Employees
Year Founded: 2004

What We Do

Liquidia is a biopharmaceutical company developing and commercializing therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its work combines proprietary formulations, innovative drug-delivery methods, and PRINT particle-engineering technology to improve therapeutic performance. The company also collaborates with pharmaceutical partners and focuses on addressing unmet needs for patients and healthcare providers worldwide.

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