Postdoctoral Research Fellow
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 locationsin Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahantare 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 formatslead 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:
Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
The 2022-2024 fellowship program is the inaugural partnership between Dyne Therapeutics and Northeastern University to offer a unique fellowship opportunity in the heart of the Boston area. The program set out to equip postdoctoral PharmDs with the skills necessary to develop the advanced therapeutics of the future. The goal was and remains the same: to cultivate the future leaders of biotechnology and allow fellows to pioneer new therapies for patients.
Dyne fellows are grounded in their core expertise area but utilize the fellowship's flexibility to branch out and discover other opportunities throughout the organization with personalized rotational experiences. Part of the backbone of the fellowship program is the Northeastern University teaching opportunities which allow fellows to share their knowledge in an educational setting.
Regulatory Affairs and Pharmacovigilance at Dyne are part of the medical organization with diverse scientific, technical, and clinical expertise. The team is responsible for creating and implementing global innovative strategies to support expedited drug development and approval of Dyne's products. Assuming increasing responsibility over the two years, the Global Regulatory & Pharmacovigilance fellow will gain hands-on experience by participating in unique opportunities within the rare disease space.
Dyne Regulatory Affairs
Gain experience working on programs that span the entire development lifecycle
Understand and develop knowledge in three focus areas of Regulatory, Regulatory Strategy, Regulatory operations and Regulatory CMC
Understand the fundamentals of both US and global regulatory
Develop skills in Medical Writing
Understand how the study-level documents are created and how individual studies support the overall drug development process
Develop an understanding of and provide support for a pharmacovigilance process designed to identify, evaluate, and minimize potential safety risks relative to benefits in Dyne clinical trials
Engage in and gain an understanding of safety surveillance activities
Gain exposure to and experience with processing of individual case safety reports (ICSRs)
Support safety surveillance and aggregate reporting, including preparing and reviewing risk management plans, evaluation reports, and safety aggregate reports
Gain experience with managing the adverse event reporting process including data collection, review, triage, adverse event report assessment, reporting and submissions of ICSRs
Gain understanding of clinical trial safety, ICSR reporting requirements, global pharmacovigilance regulations and guidelines, safety data exchange agreements, and vendor oversight
Partner cross-functionally in the conduct of pharmacovigilance activities
Experiences within early-stage clinical biotech organization including Clinical Operations, Clinical Development, Commercial Readiness & Strategy Development
Northeastern University School of Pharmacy
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
Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern's unique co-op program
Create, present, and publish scholarly research through collaborative industry and university relationships
Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery
Network with local residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees
10 Months Regulatory
- Reg CMC, Reg Strategy, Reg Operations
- Medical Writing
- US/Global Regulatory
10 Months Pharmacovigilance
4 Months Elective
- Medical Affairs
- Clinical Development
- Clinical Operations
The fellows will primarily work at Dyne's office in Waltham, Massachusetts. Northeastern University responsibilities will be carried out on the Northeastern Boston campus.
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 Dyne Therapeutics and Northeastern University
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st, 2021:
- 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, 2021. 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
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://careers.pageuppeople.com/879/cw/en-us/job/507685