Alexion Pharmaceuticals, Inc.
The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director will drive the scope of work, oversee CROs and will 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 and may be a member of the Core Team depending on the scope of the project.
Job Duties & Responsibilities
Accountable for the planning, implementation and execution of pivotal clinical trials, including study deliverables, milestones and data quality. Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors.
Oversee third party vendors to operationalize these study specifications.
Directs the 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.
Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. 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.
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.
Communicates clinical studies performance data to other members of the management and scientific team.
Prepare and maintain required study and regulatory documentation, e.g.:, reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.
Participate in and/or lead departmental initiatives.
>10 years’ of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials.
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
Ability to lead cross-functional teams and to provide management oversight of CROs.
Experience in developing study budgets, forecasting and financial oversight of a project.
Advanced degree (Master, PhD, MD) is desirable.
PMP certification desirable.
Boston, MA, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
Apply for this job at https://alexion.contacthr.com/60611562
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Alexion Pharmaceuticals, Inc.
Website : http://www.alexion.com
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with severe and life-threatening diseases that are also ultra-rare. Patients with these devastating diseases often have no effective treatment options, and they and their families suffer with little hope.