Director, CMC Project & Portfolio Management

The Director, CMC Portfolio and Project Management (PPM) is responsible for developing and implementing the vision and operating model for MacroGenics' Tech Ops portfolio and project management function. This individual will ensure execution of activities related to MacroGenics' pipeline, CDMO programs and other cross-functional projects and operational excellence initiatives. The director works closely with CMC Project Managers / Program Leads to guide the development and implementation of strategic and operational plans in support of MacroGenics' pipeline and CDMO Project Managers to ensure performance targets, budgets and timelines are met. The Director champions the development of standardized processes, systems and tools across TechOps, Quality and Regulatory CMC functions.

Responsibilities and Job Duties:

• Leads the development of a detailed cross-portfolio CMC plan, and interfaces with cross-functional representatives to identify risk mitigation, resource optimization, and acceleration strategies for individual programs. Ensures alignment of the CMC portfolio with business objectives. Responsible for overseeing CMC portfolio timelines, goals and dashboards; developing metrics and monitoring tools to track CMC portfolio progress.
• Establishes and maintains effective communication channels to provide accurate information about program achievements, issues and risks to the senior leadership team, functional line management, and other governance bodies (internal and external) as required. Proactively manages portfolio issues and opportunities to ensure that risks and mitigation strategies are identified early and escalated effectively to the appropriate governance teams and senior functional management.
• Manages the senior CMC governance team meeting and supports consistent performance of CMC governance committees to ensure transparency, effective communication, and adherence to good decision-making principles.
• Drives effective alliance management for the CDMO programs by providing guidance to CDMO PMs to establish collaborative partnerships to ensure transparency, communication, and adherence to good decision-making principles.
• Leads initiatives to cultivate new CDMO business clients by developing and executing the marketing roadmap, engaging prospective clients, and overseeing preparation of proposals.
• Coaches and mentors CMC Project Managers / Program Leads and CDMO Project Managers to effectively and proactively present options for solving complex team and/or project issues, ensure teams and stakeholders have the right information for decisions and can lead the team through problem solving, decision discussions and contingency planning and anticipate and identify project risks and develop action and resolution plans.
• Creates a performance and accountability-based culture through coaching of direct reports and matrix management of indirect reports. Facilitates individual professional development by focused 1:1 discussions and identifying and assigning opportunities for growth.
• Performs additional responsibilities as designated by management.

Minimum Qualifications

Education & Credentials

• BA / BS degree in a relevant scientific or engineering discipline or equivalent combination of education and experience

Experience

• At least 11 years' (BA/BS) or 9 years' (MS/PhD) experience in biotech/pharma industry
• 8+ years (BA/BS) or 6+ years (MS/PhD) prior experience managing complex CMC projects including late-stage pharmaceuticals in a biologics development or manufacturing environment
• 5+ years direct supervisory and/or team lead experience
• Prior experience with creating strategy and long-term planning
• Experience creating and managing integrated timelines
• Experience working with corporate partners and alliance management
• Direct experience in one or more areas of CMC biopharmaceutical product development (e.g. process development, technical services, manufacturing)

Knowledge, Skills and Abilities

• Demonstrated leadership skills are required
• Action oriented with strong sense of urgency
• Strong interpersonal and influencing skills with demonstrated ability to work with cross-functional teams, internal and external stakeholders
• Strong collaborative skills, ability to engage cross-functional leaders to resolve complex issues.
• Ability to articulate strategic impact to team and stakeholders
• Strong written and verbal communication skills are required
• Budget planning and management
• Demonstrated understanding of advanced project management principles applicable to bio/pharma
• Demonstrated ability to balance scientific, technical and business objectives
• Capable of concurrently and efficiently managing multiple projects
• Ability to perform in a fast-paced environment with competing priorities under tight deadlines
• Significant knowledge of both internal and external PM tools and software, methodologies and principles to drive the PPM function.

Supervisory Responsibilities

• Project Managers at various levels

Preferred Qualifications

• MS / PhD degree in a relevant scientific or engineering discipline or equivalent combination of education and experience
• Professional project management certification