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. Critical to the success of the program is our ability to prepare Fellows to meet the ongoing workforce needs in various areas of industry.

Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching.

In partnership with Northeastern University, Vertex Pharmaceuticals is offering a two-year Clinical and Quantitative Pharmacology (CQP) PharmD 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 acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.

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 14 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:

CQP comprises of both Clinical Pharmacology (CP) and Modeling & Simulations (M&S). CP provides pharmacokinetic (PK) and pharmacodynamic (PD) expertise, and M&S provides model-driven PK and PK/PD quantitative pharmacology expertise. Both roles are crucial at all stages of drug development.

Vertex provides an opportunity for fellows to tailor their experience to focus on Clinical Pharmacology or Modeling & Simulations. A CP fellow will learn various aspects of a clinical pharmacologist’s role, ranging from operational support to rigorous scientific analyses and drug development strategy. An M&S fellow will learn various aspects of a modeler’s role in the drug development process while focusing on specified deliverables for a specific program. If the CP or M&S fellow is interested in obtaining experience in the other field, additional opportunities can be provided upon request and availability.

For all CQP Fellows:

• Train on software utilized in CQP (e.g., NONMEM, R, or Phoenix WinNonlin)

• Participate in relevant project strategy planning and development

• Analyze and interpret clinical trial results
  

Clinical Pharmacology focused fellow:

• Design and lead clinical pharmacology studies (first-in-human, bioavailability, drug-drug interaction, immunogenicity, etc.)

• Conduct PK (noncompartmental) analyses

• Serve as clinical pharmacology lead and provide clinical trial operations support

• Author clinical pharmacology sections of clinical study reports

• Provide clinical pharmacology support to regulatory documents
  

Modeling and Simulations focused fellow:

• 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

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.

Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2024.

Curriculum vitae (CV), uploaded

Unofficial PharmD transcripts, uploaded

Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 22nd, 2024. LOR writers should include the candidate’s name and fellowship program(s) in the subject line (e.g. Smith, John – Alnylam, GSK).

Address cover letter and three LORs to:

J. Andrew Orr-Skirvin, PharmD, BCOP

Clinical Professor, School of Pharmacy

Chair, Department of Pharmacy & Health System Sciences

Director of Pharmaceutical Industry Fellowship Program

360 Huntington Ave, 140TF R218

Boston, MA 02115