Director, Clinical Project Lead

30837
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, Clinical Program Lead is responsible for strategic oversight and operational accountability of a robust clinical development program and direct report management of resources (e.g., Clinical Project Leads) within their therapeutic area. The Director Clinical Program Lead will ensure alignment and accountability with other Clinical Development functions for operational activities according to quality, schedule, and budget. As a direct report manager, the Director will oversee clinical operations resources (e.g., CPLs) in the operational conduct of clinical studies.
You Will Be Responsible For

• Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
• Leads and provides oversight to Senior Manager CPLs and Associate Director CPLs assigned to related Programs, ensuring consistency across all studies within the Program.
• Contributes strategic and operational assessment (i.e., risk management/feasibility assessment) to the development of the Global Development Plan (GDP).
• Establishes the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.).
• Acts as a core member of the Global Project Team, representing Clinical Operations.
• Accountable for the implementation and execution of a high priority Clinical Programs, including all clinical trials under the Program including both insourced and outsourced studies.
• Collaborates with the appropriate Functions in defining the sourcing strategy for the development programs. Partners with Country Operations Management to deliver insourced studies and provides oversight and management of CROs in outsourced studies.
• Provides input to Program & Portfolio Management, in case of project prioritization exercises within the portfolio.
• Accountable to GPT Leader for planning, tracking and forecasting the Global Clinical Operations budget, resources (allocation) and timelines for the program against the agreed goals.
• Reviews all key deliverables (e.g., Protocol, ICF, www.clincaltrials.gov posting, CSR, etc ) for consistency across the program. Ensures compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and EU Clinical Trial Directive throughout the entire clinical development plan. Develops in-depth knowledge of the clinical data and ensures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence.
• Leads or contributes to the Development Operatoins functional excellence efforts and initiatives, which affect cross- functional processes, as requested.
• Directly accountable and responsible for the planning, implementation and execution of pivotal, high corporate priority, key clinical trials.

You Will Need To Have

• Leadership, project management, resource management are required.
• Ability to lead cross-functional teams and to represent clinical operations in Core - Product Development Teams. Solid understanding of integrated development process for pharmaceuticals products.
• >12 years of clinical research experience, 8 of which in leading roles accountable for the planning, execution and reporting of global clinical trials of diverse development phases (I – IV)
• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We Would Prefer For You To Have

• Line management experience is desirable.
• PMP certification desirable.
• Extensive experience for financial oversight of a global clinical development program is desirable.

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, 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 [email protected]. Alexion participates in E-Verify.
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.