Position Overview

The Director, Program Management is a hands-on program manager responsible for driving cross-functional planning and execution across two assets at different stages of development. First, this role will serve as the program manager for our first ADC program as it transitions from early to late-stage development, building the integrated development plan, operating cadence, and governance infrastructure required to carry the asset forward. Second, this role will support an early-stage asset within our radiopharmaceutical portfolio, serving as both the program manager and the CMC project manager from candidate selection through IND-enabling activities and early clinical evaluation.  

This is a broad role that spans the development lifecycle and calls for a program manager who can drive stage-gate readiness for a maturing program while establishing the plans and processes that set an emerging one up for success. Reporting to the Senior Vice President of Project and Program Management, the successful candidate will partner closely with Research, Nonclinical, CMC, Clinical Development, Clinical Operations, Regulatory Affairs, Quality, and external partners to translate program strategy into actionable plans, align teams to the critical path, and provide decision-ready reporting to governance forums and senior leadership. This position will also contribute to evolving the program management operating model, tools, and templates to support a growing pipeline.  

Responsibilities

ADC Program Management – Early to Late-Stage Transition  

• Serve as the program manager for our first ADC asset, owning the integrated development plan across clinical, nonclinical, CMC, and regulatory workstreams. 
• Drive the operational transition from early to late-stage development, evolving team structure, planning rigor, and governance cadence to meet late-stage requirements.  
• Build and maintain the integrated program timeline and critical path; proactively identify sequencing conflicts, resourcing constraints, and long-lead items. 
• Drive preparation for key stage-gates, health authority interactions, and governance decision points, ensuring materials and recommendations are decision-ready.  

Radiopharmaceutical Program Management – Early Stage  

• Serve as the program manager for an early-stage radiopharmaceutical asset, supporting the cross-functional team from candidate selection through IND-enabling activities and early clinical evaluation. 
• Develop the integrated early development plan spanning discovery deliverables, nonclinical studies, CMC, regulatory strategy, and first-in-human readiness.  
• Coordinate workstreams into a single critical path and drive candidate selection and IND stage-gate readiness. 
• Anticipate and plan for the operational and supply considerations specific to radiopharmaceutical development.  

CMC Project Management  

• Represent CMC on the core product development team, serving as the point of accountability for CMC deliverables, timelines, and risks. 
• Develop and drive integrated CMC timelines to meet the needs of the product development team, coordinating activities across CMC functions.  
• Serve as the primary liaison to contract manufacturing organizations and other external partners, managing scope, deliverables, and schedule adherence. 
• Direct the CMC budgeting process for the program and manage project spend to target.  

Cross-Functional Team Coordination  

• Coordinate cross-functional teams spanning research, nonclinical, CMC, clinical development, clinical operations, regulatory affairs, quality assurance, and external partners. 
• Facilitate core team and sub-team meetings; drive agendas, capture decisions and actions, and hold the team accountable to commitments. 
• Foster a collaborative, transparent, and high-accountability team environment across both programs.  

Stakeholder Engagement and Reporting  

• Serve as the primary point of contact for internal and external stakeholders on program status, ensuring transparent communication of progress, risks, and mitigation plans. 
• Prepare and present program updates, performance metrics, and outcomes to senior leadership and portfolio review forums.  
• Direct the preparation of program dashboards, timelines, and executive presentations.  

Risk and Issue Management  

• Proactively identify program risks across technical, operational, supply, and regulatory dimensions. 
• Develop, own, and drive mitigation and contingency strategies throughout the program lifecycle.  
• Maintain and actively manage the program risk register; escalate with clear options and recommendations.  

Budget and Resource Management  

• Partner with Finance and functional leaders 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.  
• Secure and allocate resources to ensure efficient use across both programs.  

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, GxP expectations, and regulatory guidelines.  

Program Management Operating Model  

• Develop and implement metrics to evaluate program performance and use data-driven insights to recommend strategic adjustments. 
• Contribute to the development and adoption of program management best practices, templates, dashboards, and tools across the portfolio. 
• Support additional projects and initiatives within the project management organization as the company continues to grow. 

Qualifications

• Bachelor’s degree required in a technical or scientific field such as chemistry, chemical engineering, pharmaceutical sciences, biology, or a related life sciences discipline; advanced degree (PhD, MS, PharmD, MBA) preferred. 
• Formal project management training or certification (e.g., PMP) highly desirable. 
• 8 to 10 years of project and program management experience within the biotechnology or pharmaceutical industry preferred, including both drug development program management and CMC project management experience.  

Knowledge and Skills

• Demonstrated success managing programs across multiple stages of development, including experience supporting the transition from early to late-stage. 
• Direct, hands-on CMC project management experience, including ownership of manufacturing timelines and external manufacturing partnerships.  
• Proven track record driving cross-functional core teams and managing complex, interdependent programs in a matrixed environment.  
• Strong working knowledge of drug development functions and their key interdependencies, along with familiarity with FDA and EMA requirements and industry standards.  
• Excellent cross-functional communication skills, with the ability to influence and build relationships at all levels of the organization.  
• Demonstrated ability to manage multiple priorities in a fast-paced environment, with strong problem-solving and decision-making abilities.  
• Proficiency in project management tools and software (e.g., Smartsheet, MS Project, Asana) and high proficiency in MS Office Suite (Word, Excel, PowerPoint).  

Preferred Experience  

• Experience with antibody drug conjugates, radiopharmaceuticals, or other targeted oncology modalities. 
• Oncology development experience and exposure to both large molecule and small molecule programs.  
• Experience supporting regulatory submissions and health authority interactions (e.g., IND, CTA, briefing packages).  
• Experience in a small to mid-size biotech environment where building process and infrastructure is part of the role.