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Alexion Pharmaceuticals Director, CMC Program Management in New Haven, Connecticut

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Director, CMC Program Management is the senior program/project and operational excellence leader for the CMC Project & Program Management group within Product Development & Clinical Supply (PDCS) for all early and late stage development assets. The broader CMC Program Management organization is specifically responsible for program timelines, milestones, reporting and program governance as it pertains to CMC Team structure and ways of working, project Gantt Charts, meeting planning, integration support, meetings scheduling and minutes, action items/follow-ups, amongst others. He/she provides global project management support to the CMC Teams within PDCS, if needed, and drives industry-leading PM best-practices to align cross functional stakeholders. They are responsible for management and delivery of the Integrated CMC Program timeline, inclusive of key cycle-based deliverables and milestones from functional lines within PDCS and CMC business partners starting from target selection up though first product approval.

You will be responsible for:

  • Champions the Astra Zeneca Rare Disease (Alexion RDBU) governance model by driving accountability at the CMC Team level through ways of working, preparation for PDCS leadership review ahead of governance interactions and major Investment Decisions, as well as continuous process improvement

  • Leads development of the Integrated CMC Program Plan that incorporates deliverables across all relevant CMC functions (DS, DP, Analytical, Device, Clinical Supply, RA-CMC, QA, etc)

  • Leads end to end CMC program execution to ensure optimization of CMC Team tactical plans and cross functional related activities

  • Partners with CMC Team Lead and functional stakeholders to compile the CMC program budget at an asset level to drive AOP and MTP creation, as well as ensuring adherence and contribution to the quarterly budgeting and forecast revision process.

  • Leads CMC program execution, operational excellence, and program level reporting by providing robust project and program management tools and practices to ensure delivery of major cycle-based terminal milestones in accordance with the GMT/GPT goals, inclusive of CMC IND readiness, supply readiness, and major market authorization filing, amongst other pre-defined intermediate milestones specific to CMC

  • Proactive management of the critical path, operational feasibility of strategic plans, active identification, and management of project risk (risk registers, etc), and alignment of operational execution.

  • Manages the project schedule, budget, and resource information, investment options to enable efficient and effective CMC-centric portfolio management.

  • Leads the team in the preparation, implementation and maintenance of integrated program level risk management plans including risk identification, assessment, and action plan with negotiated trigger criteria, resource requirements, and impact.

  • Partners with the team to identify contingency and risk mitigation strategies for project/program level plans and negotiates the preferred team option to achieve this most rapidly for the lowest cost while maintaining acceptable quality.

  • Mentors junior members of the CMC PM organization, as applicable.

    You will need to have:

  • Minimum of 8-10 years of experience managing and leading multiple complex projects/programs of relevant experiences within the biopharmaceutical industry.

  • Demonstrated success in leading and negotiating in a matrix-based organization.

  • Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective.

  • Strong track record in executing effective project management in cross-functional drug development teams in the biopharmaceutical industry.

  • Excellent knowledge of project management discipline and its application to pharmaceutical drug development required to deliver time, cost, quality, and risk management to teams.

  • Demonstrated results in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and fiscal awareness.

  • Demonstrated ability to effectively implement the tools and techniques of the project management discipline, such as the development and management of multi-disciplinary program level integrated operational plans, critical path management, project risk management, decision analysis and meeting management.

  • Pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans, manufacturing operations and regulatory interactions

  • Bachelors’ degree in business or scientific discipline required. Masters degree in project management, business administration or other relevant field a plus.

*LIDI-1

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

Alexion 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, parental status (including adoption or surrogacy), pregnancy (including childbirth, breastfeeding, or related medical conditions), 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.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here (https://careers.astrazeneca.com/) .

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