Agios Fellowships

About Clinical Development, Clinical Scientist Fellowship

Clinical development is responsible for the architecture of clinical trial concepts, protocol development, study start up, study execution, data review and cleaning, clinical interpretation of data, publication contributions, and serves as a clinical resource for regulatory filings and queries from authorities and sites. Within clinical development, clinical scientists play a role on the clinical trial working group (CTWG). They work to help align and execute on study goals and strategy within the clinical trial working group, serve as a resource for investigators on patient eligibility, safety, and protocol questions, and partner cross-functionally with early or late-stage clinical development, medical, and commercial teams.

Clinical Development, Clinical Scientist Fellowship Goals and Objectives

The fellow will gain hands-on knowledge of US and Global clinical development at Agios. The fellow will gain experience in clinical trial-related activities within the cross-functional clinical trial working group and gain an extensive understanding of the responsibilities of a clinical scientist. The fellow will:

• Develop a strong clinical development knowledge base and be able to apply their skills practically.
• Obtain well-rounded knowledge of country or region-specific clinical trial processes.
• Cultivate strong communication and project management skills.
• Collaborate cross-functionally with various departments within the company and with key external collaborators as a partner in the clinical development process.

Clinical Development, Clinical Scientist Program Design

The fellow will join our dynamic Clinical and Translational Development (CTD) function in the Research and Development organization at Agios and will be given a plethora of opportunities to learn the business of rare disease drug development. Fellows at Agios are given the opportunity to grow into integral team members through meaningful, hands-on experiences that evolve over time. As they take on increasing responsibility and gain exposure to a wide range of projects, they make a tangible impact across the organization. Within the Clinical and Translational Development (CTD) function, the Clinical Scientist team offers a dynamic environment where fellows can grow professionally, collaborate with a diverse and enthusiastic group of researchers, and take advantage of valuable learning and development opportunities.

Year 1: Clinical Development

• Learn the purpose and goals of a clinical scientist across different phases of clinical development.
• Gain an understanding of the structure and function of a clinical trial and the roles and responsibilities of a clinical scientist within study start up, execution, and closeout.
• Collaborate with key team members and functions who are part of clinical trial working groups at Agios, such as Clinical Operations, Regulatory Affairs, Data Management, and Safety for assigned trial(s).
• Become familiar with clinical trials being run at Agios (Phase 1-3, Adult and Pediatric, and clinical pharmacology) and participate in the review and analysis of study data.
• Independently review contracts, study documents, clinical data and protocol deviations for assigned trial(s).
• Perform initial review of key study documents.
• Develop a working knowledge of GCP and ICH.

Year 2: Clinical Development

• Contribute to initial authoring and/or review of key study documents (Protocol, Informed Consent Form (ICF), Investigator Brochure (IB), Lab Manual, etc.).
• Respond to site queries and regulatory authority queries in conjunction with clinical scientist (CS) 
• Contribute to clinical data review activities across an indication/molecule.
• Assist in development  of clinical data review standards and timelines with cross-functional teams.
• Play a role in preparing for functional review of program milestones and data supporting milestones such as interim analyses, database locks, publications, clinical advisory boards and clinical study reports (CSR), etc. as needed for assigned trial(s).
• Serve as a clinical contributor for other relevant activities (analysis plans, filing, data monitoring committee, clinical advisory boards, etc.) as needed for assigned trial(s).

About Medical Affairs

Medical Affairs at Agios develops the strategy for and manages external engagement with healthcare practitioners. This strategy and engagement require the development and delivery of educational content including reactive educational slide decks, symposia, abstracts, publications, and other scientific content. Supporting multiple growing development programs, the group strives to utilize industry expertise to deliver accurate and timely scientific information to enable clinicians to make the best and most informed decisions on behalf of their patients.   

Medical Affairs Fellowship Goals and Objectives 

The goal of the medical affairs program is to allow the fellow to gain hands-on knowledge of Medical Affairs activities within the organization and gain an extensive understanding of the drug development process. 

Objectives include: 

• Applying their clinical training and scientific background to learn about disease state and the clinical development of medications within the Agios pipeline, including but not limited to pyruvate kinase deficiency, thalassemia, and sickle cell disease 
• Cultivating strong communication and project management skills 
• Collaborating cross-functionally with various departments within the company as a partner in the product development process 
• Effectively coordinating activities and communicating with vendors to support multiple functions’ efforts to educate external health care practitioners 
• Gaining a full understanding of Agios’ portfolio and the specifics of the clinical data for each program (pyruvate kinase deficiency, thalassemia, and sickle cell disease) 

Medical Affairs Fellowship Program Design 

As a fully integrated member of the Medical Affairs team at Agios, the fellow will have the opportunity to rotate through different functional groups to experience the breadth of roles and responsibilities available within Medical Affairs.  The fellowship will culminate with a long-term project with the program medical director and scientific communications team, leveraging the skills developed throughout the program to support the ongoing strategic vision of the medical affairs program. 

Year 1: Medical Affairs 

• Develop and update medical information standard response summaries with new publications, congress data, press releases, clinical trial information, etc. 
• Perform literature searches on a case-by-case basis as needed 
• Provide accurate, complete, and timely responses to responses to medical information queries and/or direct call center to the proper source for that information or create customized responses (literature searches) for US and ex-US requestors 
• Develop in-depth knowledge on clinical data associated with clinical trials, publications, and studies in GDD related to Agios programs 
• Review promotional and non-promotional materials as a participant at Medical Legal Regulatory (MLR) Review  
• Develop and implement new or updates to scientific platform and lexicon for Agios program with newly generated data, messaging, program milestones, etc. 
• Support digital and traditional global scientific communications activities including development and execution of medical content for medical affairs microsite, reactive slide decks, congress materials, innovative new methods for sharing informational materials, etc. 
• Collaborate with Global Scientific Communications Lead, cross functional internal stakeholders, and external experts/authors to create, review, and manage congress abstract/presentation as needed 
• Gain deeper understanding for industry (global) scientific communications and publication processes/requirements/best practices 

Year 2: Medical Affairs 

• Understand compliance landscape of a field Medical Science Liaison 
• Collaborate with MSL to learn about KOL engagement attend KOL meetings as appropriate 
• Support MSL lead for a clinical trial to understand the role of an MSL in clinical trials 
• Collaborate with a Congress Lead to help coordinate and plan a major conference and to understand KOL engagement at major Hematology Conferences (ASH, ASPHO, EHA, etc. 
• Understand compliance guidelines for engaging with patients and patient advocacy organizations 
• Gain an understanding of the patient advocacy strategy for the various communities and contribute to the engagement initiatives 
• Support Patient Advocacy engagement at the various in-person and virtual patient advocacy conferences to ensure a clear understanding of the patient unmet needs 
• Longitudinal Project: The fellow will participate in long-term publication planning and data generation by shadowing the medical director team and collaborating with the scientific communication team.  In addition, longitudinal experiences in patient advocacy including compliant advocacy interactions and conference attendance will be part of the long-term experience 

About Medical Safety and Risk Management

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 as well as the creation and timely submission of aggregate safety reports to fulfill global regulatory requirements. In addition, MSRM is an active participant in the creation of clear, consistent, and accurate product labeling, risk management plans, and other product-related information.

MSRM 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 global pharmacovigilance regulations, pharmacovigilance operations, aggregate safety reporting, signal detection, and risk management across all stages of drug development, from early stage to post marketing.

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

MSRM 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:

MSRM 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
• Participate in the creation of aggregate safety reports for submission to regulatory agencies worldwide
• 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

MSRM Year 2

• Take responsibility for safety for one or more protocols as a Global Safety 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 creation and maintenance of Safety Risk Management Plans
• Contribute to the safety sections of the Investigator’s Brochure and aggregate reports including DSUR, PBRER, and PADER