Alexion Pharmaceuticals Pharmacometrics Modeller in Boston, Massachusetts
Pharmacometrics Modeller position in pharmacometrics and PK/PD M&S group at Alexion is responsible for creating analytical datasets and conducting M&S work under supervision, assisting in developing and executing M&S strategies and plans in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Medical Sciences TA groups, Biostatistics, Research and other colleagues within Alexion clinical and preclinical organizations. This position will also play an important role in building the Pharmacometrics and Modeling capability within Alexion by contributing to the continuous improvement of pharmacometric technical skillset, computational infrastructure and the strategic use of M&S methodologies across our projects and disease areas, and optimizing the utility of external PMX resources.
Job Duties & Responsibilities
Responsible for organizing study data into formats needed for visualizing and creating analyzable datasets which can be used for NONMEM modeling and/or other PK/PD modeling software.
Responsible for collaborating with other development-functions or CROs to acquire and clean data in an analysis ready form
Responsible for processing results from modeling and simulation exercise to generate reportable tables and graphs
Perform population PK, PKPD-analyses, clinical trial simulations and other model based analyses
Assist, initiate and coordinate outsourced Modeling&Simulation activities when appropriate
By using state of the art Modeling&Simulation methodologies, contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin PKPD, Medical Sciences, Research, and other quantitative disciplines
Contribute to strengthen and build Alexion internal Modeling&Simulation capability on a continuous basis by participating training activities, evaluating and introducing new M&S tools and computing platform as appropriate;
Prepare population PK/PD reports and corresponding regulatory submission documents.
Responsible for contributing to the population PK/PD M&S plans
A PhD or PharmD or equivalent in PKPD M&S, quantitative system pharmacology, medical engineering is required; a master degree in the same disaplines with working experience at least 3+ year plus industry PK/PD M&S experience is required.
0 to 3 years pharmaceutical industrial experiences in the related disciplines
Possess excellent knowledge in NONMEM, WINNOLIN, R, S-PLUS and/or SAS programming
Expertise with data structures expected for analysis in programs such as NONMEM.
Skilled at plotting complex data to identify trends important for drug development
Be able to conduct PK and PKPD models with or without the supervision
Be able to contribute to, or lead the PMX related activities such as SOP development, metadata creation, etc
Excellent verbal and written communication skills
Experience from Pharmacometric approaches in Hematology, CVMD, Nephrology and Neurological disorders and rare diseases.
Experience from the application of System pharmacology methodologies in a drug research and development context
Good knowledge in Matlab, or other QSP related doftwares or computing platform
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 multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion 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). In addition, Alexion 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). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
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.
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.alexion.com.
Alexion is an Equal Opportunity /Affirmative action employer