Agios Fellowship Program

The goal of the Agios RA–CS Fellowship Program is to provide the fellow with hands-on globL experience in order to develop a comprehensive understanding of regulatory's role in the 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 RA–CS team at Agios, the fellow will be provided with a variety of opportunities for growth and development within the oncology portfolio. Through an intensive and cultivating environment, the fellow will gain hands-on global regulatory experiences to 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 part of a cross-functional team to support global drug development.

Through the afforded mentorship, leadership, and empowerment of the fellowship team at Agios, the fellow will have access to the following responsibilities:

Year 1

• 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 (U.S. and ex-U.S.)
• Contribute towards any additional regulatory input or action required for the management of clinical trials

Year 2

• 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
• Lead cross-functional teams through appropriate processes to comply with regulatory driven commitments
• Support (and potentially drive) the planning and preparation for U.S. and global health authority interactions

For more information or questions, please contact:

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

The goal of the Agios RA–CMC Fellowship Program is to give the fellow hands-on knowledge of US and Global regulatory affairs CMC, including an extensive understanding of the drug development process, CMC dossier planning and development, and competent authority interactions.

Objectives include:

• Developing a strong understanding of US and global CMC regulatory guidance and industry practice

• Obtaining well-rounded knowledge of the process for planning, preparing, and submitting CMC dossiers

• Cultivating strong communication 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 RA–CMC team at Agios, the fellow will be provided with an 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. Over the two years, the fellow will take on projects of increasing scope and responsibility while obtaining a deep comprehension of RA–CMC’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

• Integrate into the Technical Operations/CMC teams

• Support the RA–CMC leads in obtaining source documents, preparing regulatory filings, and tracking regulatory approvals globally

• Observe how to develop regulatory CMC strategy, including a deep-dive into global regulatory requirements

• Gain a solid understanding of the on-going regulatory activities, including Clinical Trial Application submissions and amendments

• Continue to take on more responsibility for regulatory submission planning and strategy

• Assist in authoring responses to competent authority queries

Year 2

• Take responsibility for an early phase development program as the RA–CMC lead

• Be responsible for planning, preparing, and submitting CMC amendments and responses to competent authority queries

• Provide strategic leadership for the technical operations/ CMC teams

• Represent RA–CMC on Regulatory Affairs sub-teams

• Participate in the development of templates and best practices documents

• Analyze metrics around health authority approval timelines and query topics/resolution

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