Two-Year Fellowship Program: Regulatory Affairs- Rare Genetic Disorders and Oncology
Agios, in collaboration with MCPHS University, offers a unique fellowship program to promote the role of the Doctor of Pharmacy (PharmD) within the biopharmaceutical industry. A fellow gains extensive experiences through various practical activities in both industry and academic settings, which could enhance the potential for accelerated career development.
Fellowship Overview
This fellowship program is designed to offer Doctor of Pharmacy graduates in-depth experience within a biopharmaceutical industry setting. In addition, PharmD graduates will have the opportunity to enhance their clinical and academic background in conjunction with the MCPHS University. Overall, this fellowship program will provide the training and experiences necessary to prepare the fellow for a career in the competitive pharmaceutical industry.
Please see our brochure for additional details and feel free to review the content below.
About Agios
Agios is a biopharmaceutical company passionately committed to applying scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. Metabolism is a complex biological process involving the uptake and assimilation of nutrients in cells to produce energy and facilitate many of the processes required for cellular division and growth. Agios believes that dysregulation of normal cellular metabolism plays a crucial role in many genetic diseases. We believe Agios is a first mover in using cellular metabolism, an unexploited area of biological research with disruptive potential, as a platform for developing potentially transformative medicines. Agios intends to apply a deep understanding of metabolism, coupled with the ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and rare genetic disorders are treated.
Agios has a dynamic culture, which supports our employees’ unwavering commitment to science and patients. World-class founding and leadership teams with the experience and track record to provide the insights required to develop groundbreaking medicines lead a group of exceptional employees.
We pride ourselves on fostering an interconnected environment that encourages creative scientific collaboration across disciplines. Our unique culture, combined with the commitment and passion of our team, reflect our belief in an “other side of possible” approach to our challenges and our work.
Fellowship Goal and Objectives
The goal of the Agios Regulatory Affairs Fellowship Program is for the fellow to gain hands-on US and ex-US experience within the Regulatory Affairs Strategy Team and develop a comprehensive understanding of the regulatory drug development process from early stage to post-marketing.
Fellowship objectives include:
- Develop a strong global regulatory strategy skillset while actively contributing to regulatory planning and submissions
- Obtain well-rounded knowledge of country specific regulatory processes
- Cultivate strong communication, leadership, and project management skills
- Collaborate cross-functionally with numerous departments within the company as a partner in the drug development process
Program Design
As an integrated member of the Regulatory Affairs team at Agios, through an intensive and cultivating environment the fellow will be provided with a vast array of invaluable opportunities across both the Rare Genetic Disorders and Oncology portfolios to gain real-life regulatory experience and further enhance their professional knowledge. Assuming increasing responsibility over the two years, the fellow will obtain a deep comprehension of regulatory’s roles, responsibilities, and day-to-day tasks, as well as familiarize themselves with the cross-functional intricacies of the drug development process.
Through the afforded mentorship, leadership, and empowerment of the fellowship team at Agios, the fellow will have access to the following responsibilities:
Year One
- Assist with the planning, development, review, approval, and updating of critical clinical documents
- Apply learned strategies to support slide development, regulatory guidance, and action item resolution at cross-functional team meetings
- Understand and assist in the process to send regulatory submissions to the FDA
- Identify and assist in preparing required documents for health authority submissions (US and ex-US)
- Contribute towards any additional regulatory input or action required for the management of clinical trials
Year Two
- Represent regulatory as an integral member at cross-functional meetings by providing regulatory insight, owning action items, and contributing feedback and guidance on clinical documents
- Assume responsibility for the management and submission of clinical documents to the FDA
- Lead cross-functional teams through appropriate processes to comply with regulatory driven commitments
- Manage initial clinical trial applications and subsequent substantial amendments (ex-US)
- Support the planning for US and global Health Authority interactions and assist with document preparation
MCPHS University
As an adjunct instructor at MCPHS, the fellow may have the opportunity to:
- Develop, coordinate, and teach courses
- Co-precept pharmacy students on advanced experiential rotations
- Create and publish scholarly research and/or review articles
- Present research at scientific and clinical meetings
- Participate in professional development seminars
Benefits
The fellow will receive a competitive stipend and benefits package, including comprehensive health and dental insurance. Attendance at one or more professional meetings, conferences, or workshops will be sponsored by the fellowship program. The fellow may qualify for student loan deferment, allowing for the postponement of loan payments until the completion of the fellowship program. The lender of the student loan(s) will be able to provide specific information regarding eligibility and terms of deferment.
Certificate of Completion
MCPHS University and Agios will award a professional certificate upon successful completion of the fellowship program.
Eligibility
- The Agios fellow will be selected on a nationally competitive basis.
- Applicants must hold a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy.
- Candidates must have strong written and verbal communication skills and an interest in pursuing a career in the biopharmaceutical industry.
- All candidates must have authorization to work in the United States throughout the duration of the two-year fellowship. No visa sponsorship will be provided.
Application Procedure
Candidates are encouraged, but not required, to request a preliminary interview at the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting through the Personnel Placement Service (PPS) website.
The formal application materials must be received by December 20th. Submit via the on-line portal: http://www.mcphs.edu/BiopharmaceuticalFellowships
- Letter of intent
- Updated CV
- 3 Letters of recommendation
- Unofficial college transcript
For more information or questions, please contact:
Shane McGann, PharmD, RPh
Manager, Regulatory Affairs
Shane.McGann@agios.com