Program Integrity Director Jobs in Philadelphia, PA

Position Summary

The Associate Director (AD) partners with cross-functional project leads to drive programs from concept through commercialization. This role ensures cohesive execution across R&D, CMC, regulatory and commercial functions—delivering on time, within budget, and to quality standards.

This role provides strategic and operational leadership, proactively identifies and mitigates risks, and ensures clear communication and accountability across teams. The position also serves as an independent voice in shaping program strategies and updating senior leadership on progress, risks, and portfolio impact.

Responsibilities

• Partner with the Development Program Lead (DPL) to foster a high performing team and monitor the health and operating efficiency of the team as a unit.
• Lead creation of team norms and operating principles with a focus on cross-functional input and accountability, and robust analysis of vetted options.
• Act as an integrator within the Development Program Team (DPT) and across the enterprise to ensure alignment and connect best practices.
• Facilitate effective, science-based business decisions including development of scenarios as Ensures all decisions are assessed as to their impacts and communicated to stakeholders in a transparent and timely manner.
• Highlight interdependencies and downstream impacts of strategic decisions.
• Proactively identify risks and ensure mitigation plans are implemented.
• Develop and coordinate resource planning across DPT to ensure adequate resources are applied to the project.
• Advise on governance expectations with focus on cross-functional input and rigorous debate.
• Coach project team members and others to drive excellence and accountability and develop talent pipeline for DPT membership.
• Change Agent for continuous improvement and transformational initiatives.
• For projects that are being jointly developed, work closely with a key strategic alliance partner
• Identify and mitigate project risks during the various phases of development of Drug and communicate risks to relevant stakeholders.
• Collaborate with external CDMO, CRO, to define project timelines, establish and monitor KPIs, and manage relationships.
• Ensure that the non-clinical studies are performed as per the quality requirements of GXP.
• Facilitate effective, science-based business decisions including scenarios analysis and identification of critical path tasks
• Define budget and resource needs, create work breakdown structures, set and track deliverables, perform critical path analysis.
• Ensure program communication and report program status to team and Senior Leadership on regular basis.
• Recommend and implement best practices across program teams g., resource capacity planning, program risk management, team performance, timeline development, portfolio management.
• Work with functional leaders to ensure positive team spirit and high functioning team.
• Prepare monthly progress reports and ad hoc reports as required.
• Participate in development of Program Management tools, templates and processes. Additional tasks and projects as requested.

• Bachelor's degree in a science discipline or related field is required and preferably Ph.D.
• 10+ years of relevant pharmaceutical industry experience, with at least 2 years managing multi-functional project teams.
• Breadth of drug development expertise with solid understanding of project strategy and disease content to contribute to strategic discussions.
• Experience in pharmaceutical drug discovery and development.
• Knowledge of manufacturing and CMC changes.
• Possesses knowledge of all phases of the drug development cycle and has technical understanding toward the successful development and registration of pharmaceutical products.
• Fully trained in all relevant PM processes and can competently use and employ essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution.
• Ability to resolve complex problems and manage difficult stakeholder situations.
• Ability to lead the development of critical path analyses and support scenario planning.
• Excellent Project Management Skills - drives execution while balancing speed, quality, and PMP certification desirable.
• Demonstrated ability to think strategically, work effectively in a matrixed environment, and execute multiple projects simultaneously.
• Advanced working knowledge of MS Project or Smartsheets, Excel, OneNote, and PowerPoint.
• High level of personal integrity and strong conflict resolution and consensus building skills.
• Ability to work effectively with cross-functional teams.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.