Associate Director of Early Programs, Project Management

Position Overview

The Associate Director of Early Programs, Project Management is a hands-on program leader responsible for driving cross-functional planning and execution for early-stage pipeline assets from candidate selection through IND-enabling activities and Phase 1 clinical evaluation. Partnering with cross-functional leaders and external partners, this role translates program strategy into an integrated development plan, aligns teams to the critical path, and provides decision-ready reporting to governance forums and senior leadership to ensure the successful advancement of pipeline candidates. This position reports to the Senior Vice President of Project and Program Management and will also contribute to evolving program management tools, templates, and operating model to support a growing pipeline.

 Responsibilities

Program Management:

• Oversee the planning, execution, and monitoring of early-stage programs, from candidate selection through Phase 1 trials.
• Partner with program leads and functional leaders to define and refine program strategy and translate it into actionable plans.
• Develop comprehensive project plans, including timelines, milestones, and resource allocation.
• Ensure programs are delivered on time, within scope, and within budget.
• Drive preparation for key stage-gates and deliverables

 Team Coordination:

• Coordinate cross-functional project teams, including research scientists, clinical development, regulatory affairs, and external partners.
• Facilitate regular team meetings to track progress, address issues, and ensure alignment with program goals.
• Foster a collaborative and productive team environment.

 Stakeholder Engagement:

• Serve as the primary point of contact for internal and external for program status, ensuring consistent and transparent communication of progress, risks, and mitigation plans.
• Communicate program progress, challenges, and solutions to senior leadership and other stakeholders.
• Manage stakeholder expectations and resolve conflicts that may arise during program execution.

 Risk Management:

• Identify potential risks and develop mitigation strategies to ensure program success.
• Monitor and manage risks throughout the program lifecycle.

 Budget and Resource Management:

• Partner with Finance to develop and manage program budgets and forecasts; track spend versus plan and support prioritization decisions.
• Support program resourcing and capacity planning across functions; flag constraints early and propose options to protect the critical path.

 Documentation and Compliance:

• Ensure all program documentation is complete, accurate, and compliant with regulatory requirements.
• Maintain detailed records of program activities, including progress reports, meeting minutes, program decisions, and action items.
• Ensure programs adhere to industry standards and regulatory guidelines.

 Additional Project Support:

• Support additional projects within the project management and research teams as needed.
• Provide project management expertise to facilitate the successful execution of various initiatives.
• Contribute to the development and adoption of program management best practices, templates, dashboards, and tools across the portfolio.

 Performance Monitoring and Reporting:

• Develop and implement metrics to evaluate program performance.
• Prepare and present program updates, performance, and outcomes to senior leadership and at portfolio review meetings.
• Use data-driven insights to recommend strategic adjustments.

Qualifications

• Advanced degree in Life Sciences, Biotechnology, Pharmacology, or a related field preferred; advanced degree (MBA, MS) with relevant experience will also be considered.
• A minimum of 6 years of experience in project management within the biotech or pharmaceutical industries, with a focus on early-stage programs.

Knowledge and Skills

• Proven leadership experience with the ability to lead cross-functional teams and manage complex projects.
• Strong interpersonal and communication skills, with the ability to influence and build relationships at all levels.
• Excellent problem-solving and decision-making abilities.
• Demonstrated ability to manage multiple priorities in a fast-paced environment.
• Proficiency in project management tools and software (e.g., Smartsheet, MS Project, Asana, Trello).
• Strong understanding of early drug development functions (Nonclinical, CMC, Regulatory, Clinical Operations) and their key interdependencies; oncology experience preferred.
• Familiarity with regulatory requirements and industry standards (e.g., FDA, EMA). Regulatory submission experience preferred.
• Experience with data analysis and performance measurement techniques.
• High proficiency in MS Office Suite (Word, Excel, PowerPoint).