<p>Job Summary</p> <p>Responsible for planning and execution of product development projects. Plans and directs schedules and monitors budget/spending. Ensures consistent practices throughout all phases of the project life cycle. Drives the development and manages the execution of high quality, integrated cross-functional plans for projects. Applies project management best practices in the development, initiation, planning, execution, control and closing of projects. Provides clear direction on product development requirements to meet expectations of external customers and business stakeholders. Interacts with research and development, manufacturing, quality, supply chain, and regulatory departments and with external stakeholders (including partners and vendors). Responsible for project performance, risk management, administration, financial management and issue resolution for functional group. May select, develop and evaluate personnel to ensure the efficient operation of the function.</p> <p>Responsibilities</p> <ul> <li>Strategic Planning: Defining program roadmaps, goals, and success metrics. </li><li>Coordination & Oversight: Managing interdependencies between multiple projects and across R&D, Manufacturing, QA/QC, and Supply Chain. </li><li>Resource Management: Allocating budgets and resources across the program. </li><li>Risk Management: Identifying, analyzing, and overcoming program risks. </li><li>Stakeholder Communication: Reporting on program status to executives and stakeholders. </li><li>Process Improvement: Implementing best practices and optimizing internal workflows. </li></ul> <p>Skills required</p> <ul> <li>Leadership: Strong leadership, negotiation, and conflict-resolution skills. Proven ability to influence and lead cross-functional teams without direct reporting authority. </li><li>Communication: Exceptional verbal and written communication, including executive-level reporting. </li><li>Technical Proficiency: Deep understanding of the dependencies between R&D, cGMP Manufacturing, Quality Control and Quality Assurance. Familiarity with project management tools, CRM software or methodology-specific software. </li><li>Thrives in a fast-paced, dynamic environment, demonstrating the ability to prioritize effectively, adapt quickly to changing needs, and deliver high-quality results under tight timelines </li></ul> <p>Education and experience</p> <ul> <li>Bachelor's degree in business administration or a related field, Life Sciences preferred. </li><li>10 years work experience in the biotech/pharmaceutical industry and a minimum of 5 years' experience managing cross-functional drug development projects. Medical device experience a plus. </li><li>Direct experience with the transition from clinical to commercial manufacturing a plus. </li><li>5+ years in upper-management or program management roles. Comfortable with "hands-on" execution. </li></ul> <p>Physical Requirements</p> <ul> <li>Prolonged periods of sitting at a desk and working on a computer </li><li>Potentially prolonged periods standing </li><li>Must be able to lift up to 15 pounds if needed </li><li>Must be willing to travel if needed </li></ul>