Alexion Pharmaceuticals Sr Director, CMC Program Management in Boston, Massachusetts
The Senior Director CMC Group Leader is a strategic leader within the Product Development and Clinical Supply (PDCS) organization within Alexion R&D. This senior level leader will have primary responsibility for programs and oversight of other CMC leader(s). As the Alexion portfolio grows this leader will be responsible for overseeing a family of products throughout the drug development lifecycle from Candidate Nomination through Approval. This is a matrix leadership role that collaborates cross-functionally to develop CMC Development plans while providing tactical direction to the execution team. This position will lead, coordinate and monitor the CMC teams progress to ensure successful implementation of the CMC strategy. The Senior Director CMC Group Leader is the primary liaison for their program(s) to the Enterprise teams (Global Product/Medicine Teams). This is a key leadership position within PDCS and involves routine interaction with senior management.
Lead the development of the CMC strategic Plan for specific product(s) within PDCS
Manage and oversee CMC leaders within PDCS cluster as applicable
Set priorities, establish team goals and plan activities to deliver the CMC strategy for the defined program(s)
Ensure operational plans are in place and highlights key dependencies between execution teams and operational plans
Represent the CMC team as the sole point of contact to the Global Product or Global Medicine Teams as appropriate)
Identify, and escalate key issues and risks according to Alexion governance
Drive decision making and the associated deliverables across all functions on the CMC Team
Represent PDCS programs at Alexion internal governance bodies
Build and maintain strong and diverse relationships across the organization, including key client groups, peers, senior management, and subordinates
Identify and implement improvements that optimize the product development processes
Minimum of 8-10 years of experience in the biopharmaceutical industry, with prior experience in a CMC leadership role
High degree of demonstrated learning agility
Demonstrated strategic thinking capabilities with forward looking perspective
Strong communication, leadership and collaboration skills are required
Solid understanding of drug development and Global Operations
Demonstrated ability to build, organize and lead teams
Prior experience as a liaison with corporate partners preferred
High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, Project and PowerPoint. Knowledge of MS Project Server a plus
Strong interpersonal skills; fluent and able to influence others in spoken and written English
- Bachelors’ degree in scientific discipline
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
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. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. 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.
As a leading employer in our industry, Alexion is proud to offer 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.