Division/College: Bouve College of Health Sciences
FT/PT: Full Time
This two-year Fellowship Program in collaboration at Northeastern University and Alnylam Pharmaceuticals is designed to offer Doctor of Pharmacy graduates an in-depth experience in a biopharmaceutical industry setting. Alnylam focus: Clinical Development is the cornerstone of data generation in delivering novel medicines to patients. The Clinical Development fellowship at Alnylam will engage the fellow in work that is a fusion of scientific knowledge and operations of trial management to support clinical trial excellence. The fellow will start the fellowship in Clinical Operations, then rotate through Clinical Research, and have the option to select other expertise areas depending on the interests of the fellow. The intent of this program is to train fellows in comprehensive clinical development activities to build a foundation for roles in as clinical drug developer.YOURIMPACT
Provide scientific, strategic, and operational support to help drive the clinical development teams towards achieving company pipeline goals and milestones
Serve as clinical support for program teams for conduct of clinical studies at clinical trial sites globally
Operational, technical, and scientific aspects of generating clinical development plans and clinical trial execution from startup through closeout
Development of key study documents, including protocol concepts and protocols (Phase I-III, natural history), data capture tools such as case report forms, procedure manuals, study operation plans, informed consent forms, clinical study reports, and IND/NDA submission documents
Engagement in ongoing medical data review, analysis, and reporting of clinical information in materials for sites, investigators, and other stakeholders
Planning and execution of investigator meetings and congresses to provide key messages about clinical trial data
Collaborative management of study contract research organizations (CROs) and other key vendors
Participate in the development of effective working relationships with key investigators to optimize scientific quality/innovation of clinical study design, execution, reporting, and publication
Process evaluation to ensure that all studies are conducted with the highest level of ethical and safety standards and in compliance with ICH/GCP guidelines and all applicable regulatory policies
WHAT WE VALUE
Strategic and analytical thinking
Cross-functional collaboration and team mindset
Creative and efficient problem solving
Core Clinical Development Strategy Rotations:
Patient Recruitment & Retention Northeastern University School of Pharmacy focus: Fellows have the opportunity to teach courses in both large and small group settings and co-precept introductory and advanced practice experiential education students. Fellows will also participate in teaching seminars with residents and fellows throughout Massachusetts and will work with Northeastern faculty in the areas of teaching and scholarly projects leading to publication and scientific presentation. The fellows will work at Alnylam's office in Cambridge, Northeastern offices on campus, as well as various clinical practice settings (hospitals, clinics, pharmacies) with Northeastern faculty.
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts, excellent communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at Alnylam and Northeastern.
Applicants MUST submit the following APPLICATIONMATERIALS by December 1, 2018: The Northeastern online application form MUST include the following items: 1. Curriculum vitae, uploaded 2. Transcripts (*may be unofficial or official), uploaded Three formal letters of recommendation (LoRs) sent directly from the letter writer, and a letter of intent will be requested from candidates who advance to an onsite interview. Letter of intent and LoRs are not required until formally requested and specific instructions will be provided upon request of these documents. Upon request, the letter of intent should be sent by the candidate to PharmDfellowships@northeastern.edu. LOR writers should include the candidate's name and fellowship program(s) in the subject line. (e.g., Smith, John – Alnylam, Tesaro & Bioverativ). The Bouvé College of Health Sciences at Northeastern University is one of nine colleges/schools at Northeastern University and is a national model for education and research in the health, psychosocial and biomedical sciences. Comprised of three schools – Nursing, Pharmacy and Health Professions — over 2200 undergraduates and 1700 graduate students are enrolled in more than 30 degree-granting programs. Complementing our instructional programs, we house nine centers and institutes and the College successfully competes for NIH, NSF and foundation funding. Northeastern University is on an exciting trajectory of growth and innovation. The University is a leader in inter-disciplinary research, urban engagement, experiential learning, and the integration of classroom learning with real-world experience. Northeastern University is home to 20,000 students and to the nation's premier cooperative education program. The past decade has witnessed a dramatic increase in Northeastern's international reputation for research and innovative educational programs. A heightened focus on interdisciplinary research and scholarship is driving a faculty hiring initiative at Northeastern, advancing its position amongst the nation's top research universities. Northeastern University is situated on the Avenue of the Arts in Boston's historic Back Bay, four blocks from the Longwood Medical Area, encompassing Harvard Medical School, Boston Children's Hospital, Brigham & Women's Hospital, and Beth Israel Deaconess Medical Center, and eight blocks from the Boston Medical Center.
Requisition Number: STFR004943
Internal Number: 57373
About Northeastern University
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.