Job Description

Job Description

The Director of Project Management will lead development and execution of planning for strategic, operational, and clinical development initiatives within a dynamic biotech environment. Reporting to the Senior Vice President of Operations, this role requires a purpose-driven leader with strong project management expertise, cross-functional collaboration skills, and the ability to shape company culture and values. The successful candidate will serve as a brand ambassador and contribute to the execution of high-priority clinical programs with a potential for transformative clinical outcomes for rare disease communities.

Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, strong project management skills, excellent planning and budgeting skills, ability to think strategically and act independently, a “hands on” approach in the implementation of an agreed-upon plan, nimble problem-solving skills, an innate sense of urgency, creative thinking about what is possible in execution, and general positivity.

In this role, a typical day may include:

• Lead cross-functional project teams from pre-clinical, product candidate selection, clinical development, regulatory submission, and commercialization.
• Develop and oversee integrated strategic and operational plans across internal functions and external collaborators.
• Establish and maintain strong relationships with all cross functional teams, including CMC, Regulatory, Clinical Operations, Clinical Development, Medical Affairs, Finance and Communications.
• Provide oversight and management of Program Management Operations in the development and refinement of standardized dashboards and reporting tools in addition to overseeing the development and maintenance of centralized and integrated systems to manage timelines, budgets and resources.
• Implement project management best practices, governance models, communication formats and software tools to maximize timely execution of corporate objectives.
• Work in partnership with cross-functional development program team leaders and individual program managers, provide strategic input on development plans, and ensure on-going alignment to project team objectives and overall execution of programs deliverables.
• Provide strategic input and alignment across development programs and ensure timely execution of deliverables.
• Lead cross-functional teams in planning and tracking activities
• Manage partnerships with biotech companies, CDMOs and academic institutions who iECURE partners with to advance development programs.
• Ensure cross-functional alignment and execution of development plans.
• Lead risk management and contingency planning.
• Act as spokesperson for the program team when needed.
• Develop and manage dashboards, reporting tools, and centralized systems for timelines, budgets, and resources.
• Coordinate clinical program studies and regulatory filings with licensee partners.
• Communicate effectively with senior leadership.
• Ensure compliance with legal, regulatory, and operational standards.

To be considered, you should have:

• Bachelor’s degree in Management, Business or equivalent specialty; MBA/MPM preferred.
• 6-10 years of progressive leadership experience in life sciences project management within a company executing early-stage clinical development programs.
• Deep understanding of drug development processes including protocol development, regulatory engagement, clinical development, and commercialization.
• Working knowledge of Technical Operations (ie. CMC) for gene therapies including manufacturing processes, assay development, and product release.
• Experience in rare disease clinical development and successful NDA/BLA submissions.
• Strong analytical, strategic thinking, and problem-solving skills.
• Excellent communication skills across all organizational levels.
• Knowledge and application of AI tools to enhance program management efficiency and outputs
• Knowledge of compliance, legal, and regulatory frameworks in the pharmaceutical industry.
• Proven leadership and team-building capabilities in a fast-paced, matrixed environment.
• Experience with budget development and management.
• Ability to travel up to 5%.

LOCATION:

Fulltime, based in Blue Bell, PA

Job Tags

Similar Jobs