Associate Director, Clinical Project Lead, Phase 1 Clinical Operations

31207
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 Associate Director, Clinical Project Lead (CPL) is ) is responsible for the implementation and execution of Phase 1 Clinical Studies. The CPL will oversee the study team and study deliverables to defined study specifications and milestones. The CPL is the primary point of contact interfacing between functional groups, investigator sites and vendors. The CPL will drive the scope of work, oversee CROs and proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Associate Director, CPL may be accountable for setting and managing operations across multiple studies.
You Will Be Responsible For

• Directs operational execution of clinical study activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity; and patient protection.
• Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.
• Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.
• Oversee third party vendors to operationalize the study specifications.
• Accountable for the planning, implementation and execution of pivotal clinical trials, including study deliverables, milestones and data quality. Lead the Clinical Trial Team. Managemetn oversight of CROs and relevant study vendors.
• Participate in and/or lead deparmental initiatives.
• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals.
• Communicates clinical studies performance data to other members of the management and scientific team.
• Key contributor to the development, review and approval of study documents including but not limited to protocol, statistical analysis plan, and clinical study report.
• Prepare and maintain required study and regulatory documentation, e.g.:, reports for Competent Authority submissions, master patient informed consent form, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets.
• 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.

You Will Need To Have

• 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; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Experience in developing study budgets, forecasting and financial oversight of a project.
• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
• >10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials.
• Ability to lead cross-functional teams and to provide management oversight of CROs.

We Would Prefer For You To Have

• Phase 1 experience preferable
• Advanced degree (Master, PhD, MD) is desirable.
• PMP certification 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.