Industry Sponsor: Takeda Pharmaceuticals
For more information, please see
this brochure
.
Program Details
During the two-year Global Regulatory Affairs: Drugs and Biologics fellowship at Takeda, the fellow:
- Serves as the primary liaison between Takeda and Global Health Authorities
- Provides regulatory intelligence necessary to generate and present information to meet the needs of key stakeholders including Global Health Authorities, patients, purchasers and prescribers
- Provides regulatory strategic input required to expedite drug development, filing and global regulatory approval of new drug or biologic products
- Collaborates with cross-functional teams to provide regulatory strategy to optimally design and implement successful drug development strategies
- Leads the development, submission and maintenance of Investigational New Drugs (INDs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs)
- Ensures compliance with global regulations and supports the interpretation of global health authority requirements
Program Staff
Justin Moots, PharmD
Senior Manager, Global Regulatory Affairs Development, Gastroenterology
Fellowship Coordinator, Takeda-Purdue GRA Fellowship
Amy Heck Sheehan, PharmD
Professor of Pharmacy Practice
Purdue University College of Pharmacy
Current Fellows
First-Year Fellows
- 2023-2025: Nicholas Ganly, PharmD
Butler University College of Pharmacy and Health Sciences, Class of 2023 - 2023-2025: Ellie Solitro, PharmD
Massachusetts College of Pharmacy and Health Sciences, Class of 2023 - 2023-2025: Teodor Lazarovski, PharmD
Regis University School of Pharmacy, Class of 2023 - 2023-2025: Antony Goldenberg, PharmD
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, Class of 2023
Second-Year Fellow
- 2022-2024: Emily Olsen, PharmD
Massachusetts College of Pharmacy and Health Sciences University, Class of 2022
Past Fellows
2022-2023: Tuyet Truong, PharmD
Manager, Regulatory Affairs
Novo Nordisk
2021-2023: Ethan Gipson, PharmD
Manager, Global Regulatory Affairs
Takeda
2021-2022: Ellen Guo, PharmD
Manager, Regulatory Affairs
Seagen Inc.
2020-2022: Ashley Idusuyi, PharmD
Senior Manager, Regulatory Affairs
BeiGene USA
2020-2022: Emily Birakdar, PharmD
Manager, Regulatory Strategy Oncology
Takeda Development Center Americas
2019-2021: Sebastian Bilitza, PharmD
Senior Manager, Global Regulatory Affairs
Relay Therapeutics
2018-2020: Justin Moots
Senior Manager, Global Regulatory Affairs Development, Gastroenterology
Takeda
2017-2019: Monica Pham
Associate Director, Regulatory Strategy Lead
Novartis Institutes for BioMedical Research (NIBR)
2016-2018: Lance Kruger
Regional Medical Director, Rheumatology
Horizon Therapeutics
2015-2017: Yijia Luo
Director, Regulatory Strategy and Registration
Cerevel Therapeutics LLC
Benefits
The fellow will receive a competitive stipend and benefits package, including comprehensive health and dental insurance. The fellowship will sponsor attendance at one or more professional meetings, conferences or workshops.
Eligibility
The fellow will be selected on a nationally competitive basis. To be eligible, candidates must be graduates of an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program before the fellowship begins in July. Participation in the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting Personnel Placement Services (PPS) is strongly encouraged, but not required. The candidate must be eligible to work in the United States, as Purdue and Takeda will not provide sponsorship to foreign students.
Application Process
Positions available: 3
All interested applicants must submit the following via email:
- Curriculum Vitae
- Letter of Intent
- Official college of pharmacy transcript
- Three letters of recommendation (Please have your letter writers send them directly to the email below)
Applications will open on October 2nd, 2023. All application materials should be submitted electronically to the email contact below, with CVs, LOIs, and official transcripts due on November 6th, 2023, and letters of recommendation due on November 13th, 2023.
Please send all correspondence to:
Justin Moots, PharmD
Takeda Pharmaceutical Company Limited
10 Green Street
Cambridge, MA 02139, USA
Preliminary interviews will be conducted virtually on a rolling basis, starting on October 9th, 2023.
To qualify for a preliminary interview, at minimum, please submit your Curriculum Vitae, Letter of Intent, and Transcript (unofficial transcript may serve as a place holder). Please note that in order for candidates to be considered for a final offer, all application materials listed above must be received by the deadline.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, Purdue University College of Pharmacy, in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 13th, 2023.