Associate Director, CMC Program Management

Company: CMC Roofing
Location: New Haven
Posted on: October 19, 2024

Job Description:

Join us as an Associate Director, CMC Program Management, a key role within the CMC Program Management group for all early and late stage development assets. This role provides global project & program management support to the CMC Teams within Product Development and Clinical Supply (PDCS). The successful candidate will manage and deliver the integrated program timeline, incorporating deliverables across functions, SMEs and indications. This role will help to drive industry-leading PM best-practices across CMC teams.Drive the development of CMC goals in partnership with the CMC Lead, enabling timely filings and delivery of clinical supply for all phases of development. You will lead the generation, alignment and continual monitoring of an integrated CMC program plan across functional lines involved in the development and delivery of supply. Own program/project level budgeting and resource management. Lead operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.

• Bachelors' degree in scientific field required
• 8+ years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or drug development PM.
• Build a highly collaborative and inclusive environment vital for the cross-functional CMC teams to be effective.
• Strong track record in driving effective program management skills in cross-functional matrix organizations.
• Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.
• Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
• Demonstrated ability to effectively implement the tools and techniques of the program and project management field.
• Advanced degree in scientific field, or business
• PM experience from candidate selection to thru approval
• PM experience with small molecules and/or biologics
• Experience with Smartsheet, Power BI and other reporting/metrics capabilities
• Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planningWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of 4 - 5 days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Joining Alexion, AstraZeneca, Rare Disease means embracing an opportunity where work isn't ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit - we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit and autonomy of a leading biotech. You'll join an energizing and kind culture where people build connections to explore new ideas and learn.Are you ready to make an impact? To drive change with integrity, supported by a culture that celebrates diversity, innovation, and the power of connection to patient's lived experiences? If this sounds like a team that you want to be a part of... then we'd love to talk. Apply now!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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Keywords: CMC Roofing, Union , Associate Director, CMC Program Management, Executive , New Haven, New Jersey