Director, Project Management, Chemistry Manufacturing & Controls (CMC) - Hybrid

Job Description

Global Project and Alliance Management (GPAM) sits in the Research & Development Division (R&D). The Project Managers in GPAM are core members of development teams at our Company. Project Managers drive these cross-functional teams to deliver projects and products that improve human health and business. 

Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans.  

Under the guidance of the CIPM Staff Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage CMC programs, due diligence and business development activities independently, regardless of complexity, phase or program type, and is based on direct experience and the ability to translate prior experiences to a new challenge. Project consultation with supervisors, rather than "oversight" is expected at this level. In addition, the Director may be expected to take on one of the following important responsibilities: 1) mentoring/coaching other PMs, including understanding their projects and developing their knowledge of drug/vaccine/biologics development, governance & team processes and PM skills; 2) management and/or administration of strategic management or governance committees and 3) delivery of major change projects that impact the company or Team performance.  

Primary Responsibilities: 

 Management of Development & Commercialization Teams (~70%) 

• Able to independently manage CMC development projects of any type, including those which require extensive experience with drug / vaccine / biologics / antibody drug conjugate development, and company processes/procedures related to CMC teams due to their significant importance to the company or degree of complexity 
• Must be able to develop high performing matrix teams with an ability to quickly identify gaps in team effectiveness and implement remediation efforts to ensure project success  
• Leverages business and financial acumen to drive project plans that optimize the portfolio with respect to timeline, cost, and resources 

Talent Development, Process Improvement, and PM Operational Support (~30%) 

• Fosters a culture that aligns with the organizational vision and act as a strong change agent with stakeholders and partners. 
• Coach more junior staff in the nuances of managing a CMC project: management of team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, coaching on Company processes relating to CMC development team management, strategic document preparation, PM skills, and Team Management.  
• Work to ensure that PM best practices are being employed across projects and serve as a role model for how best practices are put in place within CMC project teams.   
• Actively participate in departmental administrative processes which relate to talent development/ management and improving the standards of the PM organization.  
• Participate in or lead continuous improvement projects that require extensive product development experience and understanding of procedures and policies, and which significantly impact the work and / or effectiveness of PM. These projects can be cross divisional and relate to optimizing PM capabilities, systems, and operations (e,g., leading efforts to improve planning systems platforms, etc.) or to improving the functioning of teams and / or CMC development processes.  

Education Minimum Requirements:

• Bachelor’s degree required; concentration in a scientific-related discipline preferred 

Required Experience and Skills: 

• Eight (8) + years in a PM related or leadership role 
• Demonstrated ability to manage resources, time, and budget effectively for given projects; is business savvy and results oriented  
• Working knowledge of clinical drug development, with relevant experience that informs fluent understanding of the different phases of development, associated CMC deliverables, and how the various functional areas contribute to a comprehensive strategy 
• Familiar with project management tools and systems or demonstrated ability to rapidly become proficient in new tools 

Preferred Experience and Skills:

• Advanced scientific degree (Master of Science (MS), Master of Business Administration (MBA), PharmD, Ph.D.) 
• Project Management Certification (PMP) or formal coursework/training in project management 
• Experience with the planning and execution of strategies for drug product registration and commerc