Director PK-PK Modeling and Pharmacometrics (PMX) position is responsible, as a PMX project leader, for developing and executing Modeling&Simulation (M&S) plans and strategies and exposure response analyses for compounds from the early stage (first-in-human up to proof-of-concept) to the late-stage clinical development (proof-of-concept up to post market) in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Medicine, Medical Sciences, Biostatistics, Research and other colleagues within Alexion R&D organization. This position will play a key role in strengthening the PMX and Modeling capability within Alexion by strongly 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.
This position will also be responsible for his/her project related M&S assignments either executed independently or in collaboration with external PMX CROs. This position will:
1) Develop and execute population PK, PKPD, exposure response, dose selections for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies to Phase IV studies
2) Develop the quantitative system pharmacology strategies/plans and corresponding models for target identification, and compound design/characterization, translation from preclinical to FIH dose selection;
The incumbent will be responsible for the preparation of population PK/PD reports and corresponding regulatory submission documents. The incumbent will be expected to manage multiple development projects simultaneously, and will participate in discussions and presentations to senior management.
- As M&S project lead in one or more cross functional development teams, develop and execute M&S strategies/plans fully integrated with the overall preclinical and clinical plans;
- By using state of the art M&S methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin Pharm, Medical Sciences, Research, and other quantitative disciplines;
- Lead an internal matrix team(s) in building quantitative systems biology/pharmacology (QSP) to support the activities from early discovery to FIH and beyond, in collaboration with leading external QSP service providers;
- Perform population PK, PKPD-analyses, clinical trial simulations and other model based analyses when appropriate;
- Initiate and coordinate outsourced M&S activities on a regular basis;
- Mentor and coach junior M&S scientists and junior clinical PKPD scientists;
- Strengthen and build Alexion internal M&S capability on a continuous basis by initiating training activities, evaluating and introducing new M&S tools and computing platform as appropriate;
- Prepare population PK/PD reports and corresponding regulatory submission documents.
- Ten+ (for director) years pharmaceutical industrial experiences in the related disciplines of clinical pharmacology, PKPD, and QSP;
- Excellent hands-on knowledge in R, S-PLUS and/or SAS, NONMEM;
- Excellent knowledge in Mathlab, or other QSP related softwares or computing platform;
- Well versed at plotting complex data to identify trends important for drug development;
- Track record of applying quantitative system pharmacology methodologies in a drug R&D context;
- Track record of contributions to INDs, NDAs/BLAs, and various regulatory submissions;
- Track record of publishing M&S work
- Managerial experience, especially related in CRO personnel management is preferred;
- Experience from pharmacometric approaches in hematology, nephrology, metabolic, and neurological disorders and rare diseases preferred; Exposure to rare disease drug development is desired
- Excellent written and verbal communication skills
- A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired.
Boston, MA, United States
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.