Vertex – Early Development Postdoctoral Research Fellow

Northeastern University•Boston, MA

1d•$60,315 - $85,193•Onsite

About The Position

The 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 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. 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.

Requirements

Doctor of Pharmacy degree from an ACPE-accredited institution
Eligible for pharmacist licensure in the State of Massachusetts
Excellent oral and written communication skills
Strong time management and leadership abilities
Ability to work independently and take initiative on a variety of projects at both the industry site and Northeastern

Responsibilities

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 translational medicine/clinical development plans
Conduct modeling and simulation activities to aid in the design and conduct of clinical trials (e.g., dose selection, sample collection)
Author M&S reports and/or regulatory documents in support of regulatory submissions
Support design and execution of first-in-human studies (healthy volunteer or patient)
Contribute to design of early proof of mechanism (POM) strategies and studies
Contribute to design and execution of drug-drug interaction, ADME, TQT, and special population studies (hepatic and renal impairment)
Contribute to biomarker strategy development
Assist in updating investigator brochures and developing labeling language based on Phase 1 study results