Associate Director, Program Management

Role Summary

We are seeking an Associate Director, Program Management who will report into the Vice President, Program Management. You will work with cross-functional teams in the planning and execution of both early research and late-stage drug development programs. This role requires deep program management expertise in R&D activities, IND filings and lifecycle management within the pharmaceutical and biotech industry. The Associate Director will ensure projects are delivered on time, within scope, and in compliance with regulatory requirements while aligning with corporate objectives.

Responsibilities

• R&D Planning & Lifecycle Management
  • Manage a cross-functional R&D and lifecycle management team.
  • Develop, implement and maintain R&D study plans, ensuring strategies align with corporate goals and that study results are on time and within budget.
  • Drive the creation and maintenance of a R&D dashboard, providing transparency to senior leadership on R&D progress.
  • Manage and maintain complete and high-quality core program information and documents such as minutes, agendas, action items, development plans, integrated timelines, assumptions, dashboards.
  • Proactively track and transparently report on program status against approved timeline, goals, and milestones.
  • Serve as a central source for cross functional program information across the company, including senior management.
• Project Leadership & Stakeholder Management
  • Facilitate project governance, ensuring senior leadership has clear visibility into project milestones and risks.
  • Reviews R&D deliverables and ensures alignment across research, development and lifecycle management workstreams.
  • Act as a key liaison between the R&D team and executive leadership.
• Operational Excellence & Risk Management
  • Collaborating with project and functional area leads, identify project risks, key interdependencies, and proactively develop and implement mitigation plans.
  • Implement project management best practices, tools, and templates to enhance team efficiency.
  • Provides coaching and development to team members on project management methodologies.
  • Measures team performance to achieve deliverables and provide feedback to functional management.
  • Utilize data from performance metrics and feedback to identify and develop solutions for the broader teams to gain long term efficiencies.
  • Other duties as assigned.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; or relevant experience.
• Advanced degree (MBA, PhD, or PharmD) preferred.
• Minimum of Five plus (5+) years of experience in research and development programs (early and/or late) within the pharmaceutical/biotech industry.
• PMP certification preferred.
• Oncology experience preferred.
• Proven track record of leading IND enabling activities and assisting with IND filings.
• Prior experience in a line function (e.g. research, clinical development/operations, CMC, regulatory).
• Familiarity with pre-clinical and clinical regulatory requirements and compliance standards.
• Expertise in project management methodologies.
• Strong leadership, organizational, and interpersonal skills.
• Ability to manage complex, cross-functional teams and drive strategic objectives.
• Highly motivated, proactive, enthusiastic and goal-orientated to deliver on the success of the company’s R&D programs.
• Proficiency in project management software (e.g., Smartsheet).
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.