Vertex – Early Development Postdoctoral Research Fellow at Northeastern University in Boston, MA

Job description

About the Opportunity About the Opportunity Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Vertex Pharmaceuticals is offering a two-year Early Development fellowship, based in Boston, MA. About Vertex Pharmaceuticals Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and Twitter/X. Responsibilities Early Development Fellowship Description: Early Development comprises Clinical Pharmacology (CP), Modeling & Simulations (M&S), and Early Development Medical Directors (EDMD). CP provides pharmacokinetic (PK) and pharmacodynamic (PD) expertise. M&S provides model-driven PK and PK/PD quantitative pharmacology expertise. EDMD leads early clinical strategies and provides expertise in translating investigational therapies into first-in-human trials, whether they are healthy volunteers or patients. Vertex provides a structured 2-year fellowship program involving three rotations across Clinical Pharmacology, Modeling and Simulation, and Early Development Medical spanning different phases of development. Throughout the program, Early Development fellows will participate in relevant project strategy planning and development, analyze and interpret clinical trial results, and train on software utilized within the department (e.g., NONMEM, R, or Phoenix WinNonlin). The objectives specific to each rotation include: Clinical Pharmacology Rotation: • Design and lead clinical pharmacology studies (first-in-human, bioavailability, drug-drug interaction, immunogenicity) • Serve as clinical pharmacology lead and provide clinical trial operations support • Conduct noncompartmental PK analysis • Author clinical pharmacology sections of clinical study reports and provide support to regulatory documents Modeling and Simulation Rotation: • Implement model informed drug development (MIDD) using quantitative approaches (e.g., population PK, PK/PD, optimal sample design) to address critical questions during drug development • Contribute to M&S plans and/or translational medicine/clinical development plans • Conduct modeling and simul