Associate Director, CMC Program Management at Alexion in New Haven, Connecticut

Posted in Other about 11 hours ago.





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 planning

When 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!



Date Posted

11-Oct-2024



Closing Date

21-Nov-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.


AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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