Alexion Pharmaceuticals Senior Manager, Pharmacometrics PKPD in Boston, Massachusetts
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:
Senior Manager, Pharmacometrics PK/PD M&S (PMX), position is responsible, as a PMX project leader, for developing and executing modeling & simulation (M&S) analysis 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 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 this individual’s project related M&S assignments either executed independently or in collaboration with external PMX CROs. This position will
Develop and execute population PK, PKPD, exposure response, dose selections for phase1- 3 strategies/plans, and corresponding models for the pharmacometric function from early clinical studies to Phase IV studies.
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.
You will be responsible for:
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) models to support the activities from early discovery to FIH and beyond, in collaboration with leading external QSP service providers.
Lead and support 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.
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.
You will need to have:
A PhD, degree or equivalent in quantitative sciences
3+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, PKPD, and QSP.
Excellent hands-on knowledge in R and/or SAS, NONMEM.
Excellent knowledge in Mathlab, Mathmatica, or other QSP related software or computing platform.
Well versed at plotting complex data to identify trends important for drug development.
Background in engineering or clinical pharmacology is desired.
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.
We would prefer for you to have:
Experience from pharmacometric approaches in hematology, nephrology, metabolic, and neurological disorders and rare diseases preferred.
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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers 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, and much more.
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 (https://careers.astrazeneca.com/) .