Alexion Pharmaceuticals Director, Trial Master File TMF Operations in Boston, Massachusetts
The Director, Trial Master File (TMF) Operations, is the TMF business process owner, providing leadership and strategic direction to the entire R&D organization and is responsible for ensuring TMF processes and related documentation across Alexion, partner organizations and third party vendors are of the highest quality and that they comply with ICH regulations, GCP guidelines and expectations of regulatory authorities. The Director will provide oversight to the TMF operational functions/roles and, in conjunction with Development Operations and Qualitative Sciences (DOQS) Senior Management, will support/develop the global Document Governance and Management strategy, and will ensure business objectives, best practices and innovation opportunities are realized. This role will be appointed as the designated TMF archivist within Alexion and be responsible for archival activities of the TMFs.
Job Duties & Responsibilities
Drive the development and implementation of global R&D strategy as it relates to the TMF with respect to processes, systems, vendors, roles and governance to ensure that Alexion is inspection ready at all times. Serve as the primary point-of-contact for all TMF related activities.
Be the Alexion-designated Archivist and be responsible for archival activities of the TMFs in line with EMA regulations.
Direct the ongoing quality control reviews of study and program level TMFs, utilizing a risk-based approach.
Develop KPI and performance metrics, in alignment with Senior Management expectations, and establish and lead oversight and governance processes.
Ensure and oversee implementation of TMF processes in R&D line functions. Develop and deliver training on essential documents and TMF processes/expectations.
Conduct oversight of the third party vendors supporting TMF activities to ensure service meets expectations.
Manage remediation of legacy study TMFs as needed.
Maintain awareness of evolving standards, technologies and best practices and evolve Alexion TMF operating model as needed.
Manage and mentor team members responsible/accountable for TMF activities, as needed.
Clinical research professional, preferably with >12 years’ experience as a Project Leader, Project Manager or in a similar role.
Previous experience with FDA/MHRA/PMDA inspections desired.
3-5 years of people management experience.
Direct management of TMF or experience as a TMF Lead desired.
Solid understanding of integrated development process for pharmaceuticals products.
Leadership, project management, resource management are required.
Excellent oral and written communication and interpersonal skills.
Inspire others to share their vision and support them to reach a common goal.
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
Advanced degree (Master, PhD, MD) is highly desirable.
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 through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). 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). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. 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, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. 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.