Details

Posted: 17-Sep-23

Location: Boston, Massachusetts

Type: Full-time

Salary: Open

Categories:

Academic/Faculty
Medical - Clinical

Internal Number: 4605425

Postdoctoral Research Fellow, Alnylam-Clinical Development
About the Opportunity
About Northeastern:
Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.
Our locations-in Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahant-are nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.
Northeastern's comprehensive array of undergraduate and graduate programs- in a variety of on-campus and online formats-lead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.
About the Opportunity:
Northeastern University's Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. The program is a collaboration between Northeastern University and biopharmaceutical industry partners.
Our program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:

• Develop teaching skills through participation in our Teaching and Learning Seminar series
  
• Facilitate small and large group didactic education in partnership with a faculty mentor
  
• Create, present, and publish scholarly research through collaborative industry and university relationships
  
• Engage with faculty who participate in various interdisciplinary
  
• Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees
  

In partnership with Northeastern University, Alnylam Pharmaceuticals is offering a two-year Clinical Development PharmD fellowship based in Cambridge, Massachusetts.
About Alnylam Pharmaceuticals:
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by 'interfering' with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.
Responsibilities:
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 work in Clinical Operations, collaborate closely with Clinical Research, and have the option to explore other related expertise areas. 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.
Key Responsibilities:

• 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.
  

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.
Additional Information:
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31, 2023

• 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 29th , 2023. 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
Position Type
Research
Additional Information
Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.
Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.
Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity .
To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Postdoctoral-Research-Fellow--Alnylam-Clinical-Development_R118563
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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.
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