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Agios Fellowship Program

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. Currently, the following options are offered by Agios in conjunction with MCPHS University:

  • Regulatory Affairs- Rare Genetic Disorders and Oncology (not recruiting for 2019)
  • Medical Safety & Risk Management

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.

About MSRM

Medical Safety & Risk Management (MSRM) is responsible for managing the safety profile of products throughout their lifecycle through the continuous monitoring, assessment and communication of safety information. As such, MSRM plays a key role in the management of emerging safety signals in drug development and for maintaining this activity for products in the post-marketing setting. MSRM also ensures on -time reporting of high quality individual case reports and as well as the creation and timely submission of aggregate safety reports to fulfil global regulatory requirements. In addition, MSRM is an active participant in the creation of clear, consistent, and accurate product labelling and other product-related information.

Fellowship Goals and Objectives

The goal of the Agios MSRM Fellowship Program is to give the fellow hands-on knowledge of US and global pharmacovigilance activities including a broad understanding of pharmacovigilance operations, signal detection, and risk management across all stages of drug development from early stage to post marketing and to gain a broad understanding of pharmacovigilance operations.

Objectives include

  • Developing a strong safety risk management knowledge base and applying those skills practically in the arenas of signal detection and signal management
  • Obtaining well-rounded knowledge of country-specific pharmacovigilance regulations
  • Cultivating strong communications and project management skills
  • Collaborating cross-functionally with various departments within the company as a partner in the product development process

Program Design

As an integrated member of the MSRM team at Agios, the fellow will be provided with a vast array of invaluable opportunities across both the rare genetic disorders and oncology portfolios. These opportunities will enable the fellow to gain real-life pharmacovigilance experience and will deeply enhance their professional knowledge. Over the two years, the fellow will take on projects of increasing scope and responsibility while obtaining a deep comprehension of safety’s roles, responsibilities, and day-to-day tasks, as well as familiarize themselves with the complexities and cross-functional nature of the drug development process.

With the mentorship of the fellowship team at Agios, the fellow will have access to the following career-enhancing activities and responsibilities:

Year 1

  • Work with safety operations colleagues to gain a solid understanding of roles and responsibilities in individual case management and medical review of cases
  • Understand global pharmacovigilance regulations and begin applying knowledge to ensure compliance
  • Observe how safety interacts with other functions and actively participate in these interactions
  • Gain a solid understanding of signal detection, signal evaluation, and risk management activities
  • Become integrated in the cross-functional teams
  • Review safety sections of the protocol, informed consent form, and other study-specific documents ensuring accuracy and consistency
  • Assist in safety aggregate report planning, writing, and reviews

Year 2

  • Take responsibility for safety for one or more protocols as a Risk Management Lead and represent MSRM at cross-functional meetings
  • Author/review safety sections of the protocol, informed consent form, and other study-specific documents
  • Participate in generating responses to safety-related health authority queries
  • Contribute to the safety sections of the Investigator’s Brochure and Development Safety Update Report
  • Assist with the coordination of the Safety Management Team for the assigned product

For more information or questions, please contact:

Mark Novas
Mark.Novas@agios.com

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

For more information or questions, please contact:

Shane McGann, PharmD, RPh
Manager, Regulatory Affairs
Shane.McGann@agios.com