Vertex - Early Development Postdoctoral Research Fellow

Northeastern University Pharmaceutical Industry Fellowships Programis a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.

D. graduates. Akey element of the program's success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry.

In partnership with Northeastern University, Vertex Pharmaceuticals is offering a two-year Early Development fellowship, based in Boston, MA.

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 arobust clinical pipeline of investigational therapies across arange 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 1diabetes, 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.

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Early Development comprises Clinical Pharmacology (CP), Modeling& Simulations (M&S), and Early Development Medical Directors (EDMD). CP provides pharmacokinetic (PK) andpharmacodynamic (PD) expertise. M&S provides model-driven PKand PK/PD quantitative pharmacology expertise. EDMD leads early clinical strategies and provides expertise in translatinginvestigational therapies into first-in-human trials, whether theyare 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 phasesof development. Throughout the program, Early Development fellow swill participate in relevant project strategy planning and development, analyze and interpret clinical trial results, andtrain on software utilized within the department (e.g., NONMEM, R,or Phoenix Win Nonlin). The objectives specific to each rotation include:

• 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

• 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 translationalmedicine/clinical development plans
• Conduct modeling and simulation activities to aid in the designand conduct of…