Agios Two-Year
Fellowship Programs
Medical Safety &
Risk Management
Clinical Supply
Chain
Benets and Compensation
The fellowship will provide a competitive stipend and benets
package, including comprehensive health insurance. In addition,
the fellowship will offer an allowance for travel to one or more
professional meetings, conferences, or workshops. 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 specic information regarding eligibility and
terms of deferment.
Certicate of Completion
MCPHS University and Agios will award a professional certicate
upon successful completion of the fellowship program.
Eligibility
The MCPHS Biopharmaceutical Industry fellows will be
selected on a nationally competitive basis.
• Applicants must have a Doctor of Pharmacy degree from an
ACPE accredited college of pharmacy at the commencement
of the program. Applicants may be required to participate in
ASHP/PPS sponsored events to apply, but this has not been
determined to date. The program will update the application
process accordingly.
• Candidates must have strong written and verbal
communication skills and a strong interest in pursuing a
career within the biopharmaceutical industry.
• All candidates must have authorization to work in the United
States throughout the duration of the one or two‑year
fellowship. No visa sponsorship will be provided.
Application Procedure
The MCPHS application portal will open up on
October 19, 2020.
Applicants must upload the following application
materials to the online portal (https://mcphs.smapply.io/)
by November 25, 2020:
• Letter of intent
• Curriculum vitae
• Unofcial college transcript
• Contact information of three references for
their recommendations
Three recommendation evaluation forms must be submitted
no later than December 4th, 2020 via the online portal.
Interviews
The Fellowship will conduct virtual interviews during the week
of ASHP Midyear. Candidates will be notied if selected
for an interview.
Top candidates may be invited for interviews at the sponsoring
company’s location if COVID–19 restrictions allow.
Final candidates will be required to go through additional
screening/ onboarding as required by MCPHS University.
For more information or questions, please contact:
Shane McGann, PharmD, RPh
Associate Director, Regulatory Affairs
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 biopharma‑
ceutical 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.
MCPHS University
As an adjunct instructor at MCPHS University, 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 scientic and clinical meetings
• Participate in professional development seminars
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-specic 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-specic 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
• Assist with the coordination of the Safety Management
Team for the assigned product
About Medical Safety and Risk Management
Medical Safety & Risk Management (MSRM) is responsible for
managing the safety prole 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 fulll 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 pharma‑
covigilance 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-specic
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
CLINICAL SUPPLY CHAIN
PROGRAM DESIGN
As an integrated member of the Clinical Supply Chain team at
Agios, the fellow will be provided with a variety of opportunities
for growth and development within the oncology and rare
genetic disease portfolios. Through an intensive and cultivating
environment, the fellow will gain hands-on clinical supply chain
experiences to further enhance their professional knowledge.
Assuming increasing responsibility over the two years, the fellow
will obtain a deep comprehension of clinical supply chain’s role,
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:
Clinical Supply Chain Year 1
• Integrate into the Clinical Supply Chain/Technical
Operations teams
• Learn how to interpret clinical study protocols to determine
drug demand and supply strategies
• Support the Clinical Supply team in completing day-to-day
drug supply management tasks
• Observe how Clinical Supply team interacts with other
functions within Agios and external vendors and actively
participate in these interactions
• Gain an understanding of and hands-on training in applicable
clinical supply technology platforms
• Transition to full responsibility of clinical supply activities for
early phase and Investigator Sponsored Trials
• Gain exposure to the entire Supply Chain Organization,
including Commercial Supply, Clinical/Commercial Supply
Planning, and Logistics
Clinical Supply Chain Year 2
• Take responsibility for drug supply activities as a Clinical Supply
lead for one or more global clinical trials
• Be responsible for drug demand forecasting, trial monitoring &
resupply planning, study technology set-up, risk mitigation
plans, and global distribution strategy and activities
• Schedule and facilitate packaging and labeling manufacturing
with external vendors
• Collaborate regularly with Clinical Operations, Quality
Assurance, and Regulatory Affairs to efciently deliver clinical
supplies while ensuring compliance to all applicable laws and
regulations
• Contribute to program level supply planning to determine
drug product manufacturing timing and allocate inventory
amongst clinical studies
• Become procient in using drug forecasting technology to
create a drug demand model for applicable clinical studies
• Represent Clinical Supply Chain as an active member of clinical
trial working groups and project teams
About Clinical Supply Chain
The Clinical Supply Chain group at Agios develops the strategy
for and manages all aspects of drug supply for investigational
studies and expanded access programs. Responsible for
end‑to‑end supply chain management, Agios Clinical Supply
team members collaborate across a multitude of departments in
drug development and oversee activities between drug product
manufacturing and dispensation to patients at the clinic. These
activities include determination of drug demand forecasts,
development of packaging and labeling supply plans, facilitation
of manufacturing with external vendors, setting up global
distribution strategies, and development of risk mitigation plans.
As an integral part of clinical program and study teams, Clinical
Supply members also contribute to clinical study protocols,
provide guidance on patient centric packaging design,
participate in the build of randomization and trial supply
management (RTSM) systems, and develop the masking strategy
for blinded studies. Supporting multiple quickly growing
programs, the group utilizes industry expertise and explores
cutting‑edge technology to continuously improve the way Agios
delivers medications to patients.
Clinical Supply Chain Fellowship
Goals and Objectives
The fellow will gain hands‑on knowledge of Clinical Supply Chain
activities within the Technical Operations organization and gain an
extensive understanding of the drug development process.
Objectives include:
• Develop end‑to‑end clinical supply chain knowledge and be
able to apply their skills practically to drug supply
management at the clinical study and program level
• Cultivate strong communication, leadership, and project
management skills
• Collaborate cross‑functionally with various departments
within the company as a partner in the drug development
process
• Understand the requirements for supplying drug for phase
1‑3 studies, US only and global studies, blinded studies,
Investigator Sponsored Trials (IST), and Expanded Access
Programs (EAP)
• Effectively coordinate activities and communication with
vendors within an external manufacturing and logistics network
CLINICAL SUPPLY
CHAIN PROGRAM
NEW
PROGRAM
About Regulatory Affairs–Chemistry,
Manufacturing, and Controls
Regulatory Affairs–Chemistry, Manufacturing, and Controls
(RA–CMC) is a specic area within Regulatory Affairs that is
responsible for providing regulatory strategy and leadership to
support the CMC/quality modules of global regulatory lings
as well as CMC‑focused health authority interactions. The
CMC/quality modules include information on the development,
manufacture, and testing of clinical and commercial active
ingredients and drug products. The RA–CMC team oversees
the planning and execution of all quality aspects of clinical trial
applications ranging from Phase I through Phase 3 (i.e. INDs,
Investigational Medicinal Product Dossiers, Quality Overall
Summaries) as well as commercial marketing applications (i.e.
NDAs, MAAs). This team collaborates with a diverse cross‑
functional team, including technical operations, quality affairs,
supply chain, and clinical development, to assess the impact of
quality/manufacturing changes, determine the appropriate
regulatory ling strategy/timelines, and to prepare the
appropriate amendments, supplements, and variations.
RA–CMC PROGRAM
About Regulatory Affairs–Clinical Strategy
Regulatory Affairs–Clinical Strategy (RA–CS) professionals are
responsible for developing the regulatory strategy and leading
global health authority interactions to support global drug
development from pre‑IND through registration and life cycle
management. They manage the planning, coordination, and
execution of high quality regulatory submissions of original
applications (i.e. NDAs/MAAs, INDs/CTAs) and any subsequent
major amendments, supplements, and variations. The RA–CS
team interfaces with a diverse cross‑functional team to ensure
regulatory strategy is aligned with the overall development and
corporate strategy.
RA-CS Fellowship Goals and Objectives
The goal of the Agios RA–CS Fellowship Program is to provide
the fellow with hands‑on global experience in order to develop
a comprehensive understanding of regulatory’s role in the drug
development process from early stage to post‑marketing.
RA–CS PROGRAM
This program will not be recruiting for a 2021-2023 Fellow
This program will not be recruiting for a 2021-2023 Fellow
RA–CMC Fellowship Goals and Objectives
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
Objectives include:
• Develop a strong global regulatory strategy skillset while
actively contributing to regulatory planning and submissions
• Obtain well-rounded knowledge of country-specic
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
OUR TEAM
FELLOWSHIP DIRECTORS
Shane McGann, PharmD, RPh
Associate Director, Regulatory Affairs
Shane is an associate director in global regulatory affairs
for the oncology portfolio at Agios. In his current role,
Shane leads global regulatory strategic planning and
execution for the cholangiocarcinoma program at Agios. He has also
been a preceptor for MCPHS/Agios Regulatory Affairs Fellows. Prior
to joining Agios in May 2015, Shane completed a two-year post-
PharmD Regulatory Affairs Fellowship at Genzyme, in conjunction with
MCPHS University. During that time, he worked across various
regulatory teams, including CMC, biosurgery, Genzyme Canada, and
personalized genetic health. Shane received his PharmD, with a
concentration in sales and marketing, from Albany College of
Pharmacy and Health Sciences in Albany, NY.
Christina Baladi, BS
Director, Regulatory Affairs
Christina is the global regulatory affairs lead for the rare
genetic disease portfolio at Agios, responsible for
planning and executing the global regulatory strategy for
investigational therapies in various phases of development. She was
also a preceptor for two MCPHS/Agios regulatory fellow alumni. Prior
to joining Agios in June 2016, Christina worked in the regulatory
affairs group at Genentech and EMD Serono where she led multiple
initial marketing application submissions across oncology (heme and
solid tumors) and neurology, including the rst approved
breakthrough therapy treatment in the U.S. Christina received her
Bachelor of Science Degree in genetics from the University of
California, Davis.
Peter Hawkins, PhD
Senior Director, MSRM Rare Genetic Disease
Therapeutic Area Risk Management Lead
Peter is the Medical Safety therapeutic area lead for rare
genetic diseases at Agios. In his current role Peter leads
the global Safety Management Team responsible for monitoring all
safety aspects of the rare genetic disease portfolio. Prior to Agios
Peter worked at Roche and Genentech for 9 years across a number
of different activities within safety case management and had
responsibility for safety science activities for a number of early
stage oncology products. He also led the safety science onboarding
program. Peter gained his PhD in molecular biology from the
University of Warwick in the UK.
(Walter) Keith Paulick, BS
Director, Supply Chain - Clinical Supplies
Keith is the head of the Clinical Supply Chain team at
Agios overseeing both the oncology and rare genetic
disease portfolios. In his current role, Keith leads the
Clinical Supply Chain team in support of manufacturing, packaging,
and distribution operations to ensure uninterrupted clinical drug
supply for patients globally. Prior to joining Agios in April 2015, Keith
worked in clinical supply operations for Novartis managing multiple
oncology drugs in various stages of development. He has over 20+
years of pharmaceutical industry experience spanning commercial
packaging and labeling, global product sourcing, and clinical drug
supply. Keith received his Bachelor of Science Degree in pre-med
biology from Hartwick College in NY.
PROGRAM PRECEPTORS
Jennifer Brooke, PharmD, RPh
Director, Global Safety Sciences | Medical Safety
Risk Management
Jennifer is the head of the global safety sciences team
at Agios. In her current role Jennifer leads the signal
management process and creation and assessment of regulatory
required aggregate reports and risk management plans across the
Agios product portfolio. Prior to Agios, Jennifer worked in pharma-
covigilance at both CROs and pharma/biotech companies for > 10
years in a variety of therapeutic areas with a focus on rare diseases
and oncology. She also worked in medical information and as a retail
pharmacist. Jennifer received her BS in Pharmacy from the University
of Pittsburgh and her PharmD from the University of North Carolina.
Greg Smith, MS
Associate Director, Regulatory Affairs
Greg is an associate director in regulatory affairs –
chemistry, manufacturing, and controls (CMC). In his
current role, he is responsible for providing regulatory
strategy and leadership to support the CMC/quality modules of
global regulatory lings, as well as CMC-focused health authority
interactions for programs in both the oncology and rare genetic
disease portfolios. Prior to joining Agios in June 2017, Greg worked
in Analytical Development within the CMC function at Alkermes, a
global pharmaceuticals company. In this role, he was responsible for
leading a team of analytical scientists in supporting a variety of
products ranging from Phase I through Commercialization. Greg
received a Bachelors of Science Degree in Chemistry from Vanderbilt
University and a Masters of Science Degree in Chemistry from
Northeastern University, with a concentration in analytical chemistry.
Charlotte Heyman, MS
Associate Director, Regulatory Affairs
Charlotte is an associate director in the global regulatory
affairs team for the oncology portfolio at Agios. In her
current role, Charlotte is responsible for global regulatory
strategic planning and execution for two early stage
programs. Prior to joining Agios in April 2019, Charlotte spent 5 years
at Vertex Pharmaceuticals and Sarepta Therapeutics, leading
regulatory strategy on several Phase 3 programs and marketing
applications within the rare disease space. Charlotte received her
Masters of Science in Infectious Disease from the University of
London and her Bachelor Degree in Biology from Colgate University.
Carrie Cammarano, PharmD
Senior Manager, Clinical Supply Chain
Carrie is a Senior Manager in Clinical Supply Chain at
Agios. In her current role, she is a program lead within
the oncology portfolio and manages drug supply for the
Expanded Access Program and Investigator Sponsored
Trials. Prior to joining Agios in April 2019, Carrie worked in Clinical
Supply Chain at Alkermes, a global pharmaceutical company,
managing drug supply for a large multiple sclerosis program and all
Phase 1 studies. She received her Bachelor of Arts degree in
Chemistry from College of the Holy Cross and her PharmD from
MCPHS University. In 2016, Carrie completed a two-year post-
PharmD Clinical Supply Chain Fellowship at Sano Genzyme.
FELLOWS
Rolandas Urbstonaitis, PharmD, MBA
2nd Year Fellow, Medical Safety & Risk Management
Throughout my time at Agios, I have gained invaluable
experiences in medical safety and risk management
across both the rare genetic disorder and oncology
pipelines. I have and continue to take part in a variety of cross-
functional projects that have allowed me to have a positive impact on
the teams I support. As I go into my second year of the fellowship, I
am excited to lead high-visibility projects, serve as the lead risk
management representative on clinical trials, and collaborate with
driven individuals on a variety of intricate projects. The diversity and
value of my experiences at Agios have contributed to my personal and
professional growth in the past year and continue to propel me
toward a successful career in the pharmaceutical industry.
Shengmei Yin, PharmD
1st Year Fellow, Medical Safety & Risk Management
Through this opportunity with the Agios team, I have had
the opportunity to be immersed in many activities to
learn about global pharmacovigilance and interact with
other functional teams to apply good pharmacovigilance practices
and ensure compliance. From day one, the support that this program
has provided to its fellows was clear – all of the mentors within the
company have been deeply invested in teaching, preparing, and
guiding the fellows through the program. Training through project-
based learning has allowed me to quickly immerse into my role and
gain experience in pharmacovigilance activities. This team provides a
great opportunity to pursue my endeavors in an environment that is
both challenging yet extremely supportive. I look forward to the
upcoming year with the MSRM team and furthering my professional
development both within the pharmaceutical and academic space
through Agios and MCPHS.
Nnamdi Igwemezie, PharmD
1st Year Fellow, Regulatory Affairs – Clinical Strategy
As a rst-year Regulatory Affairs fellow at Agios, I feel
fortunate to have the opportunity to be directly involved
in various cross-functional projects. Within a matter of
weeks of starting my fellowship, I felt an immediate sense of
responsibility. I was immersed in countless projects, from elding
Health Authority questions to participating in regulatory strategy
development, that served as stepping stones to building condence
and understanding my role within the regulatory department. Agios
has an open and collaborative workplace culture, so everyone is easily
approachable and willing to help with my professional development.
Outside of my responsibilities at Agios, my fellowship allows me to
serve as an adjunct professor at MCPHS University, where I have the
pleasure of working with faculty through various teaching
opportunities and research projects. I look forward to strengthening
my industry skill set in the second year of my fellowship.
Nurisha Gobin, PharmD
1st Year Fellow, Regulatory Affairs – Chemistry
Manufacturing and Controls
As the rst Regulatory Affairs-CMC fellow at Agios, I was
quickly integrated into cross-functional teams to take on
high- level projects while gaining exposure to CMC strategies and
technical operations. With Agios’ diverse pipeline, I get to assist with
core regulatory proceedings at various stages of lings both in the
oncology and rare genetic disorder space. What sets Agios apart, is
the fact that we are a smaller biotech company. As a fellow here, I get
to contribute to high-level projects early on in my fellowship while
bringing my unique perspective as a pharmacy professional to
effectively contribute to the team. I am surrounded by welcoming and
hard-working teammates which gives me condence that the next two
years will be rewarding, and I eagerly look forward to expanding my
skillset in Regulatory CMC strategies and operations.
MCPHS UNIVERSITY TEAM
Amee Mistry, PharmD, RPh
Director of the Postdoctoral Biopharmaceutical
Industry Fellowship Program
Dr. Amee Mistry is Professor of Pharmacy Practice and
has been with MCPHS University since 2006. Dr. Mistry
earned her PharmD at the Albany College of Pharmacy and completed
a PGY1 Community Practice Residency with Walgreens and MCPHS
University. In 2015, Dr. Mistry took over as Director of the MCPHS
Biopharmaceutical Industry Fellowship program. She works directly
with leaders in the area to continue to foster growth and development
of the post-graduate program, and to assist the fellows in attaining
positions within the pharmaceutical industry. In addition, she is
advisor for the student IPhO chapter at MCPHS, co-advisor for
APhA-ASP, a national trainer for the APhA Pharmacy-Based
Immunization training program, and is actively involved with the
Massachusetts Pharmacists Association.
FELLOWSHIP ALUMNI
Cynthia Iyekegbe, PharmD
Mercer University
Regulatory Affairs Fellow | 2018–2020
Current Position: Manager, Regulatory Affairs
at Agios Pharmaceuticals
Shivani Pandit, PharmD
University of Pittsburgh
Regulatory Affairs Fellow | 2017– 2019
Current Position: Regulatory Affairs Manager
at QED Therapeutics
Agios is a biopharmaceutical company passionately committed to applying scientic
leadership in the eld 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 rst 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 scientic collaboration across disciplines.
ABOUT AGIOS
Our unique culture,
combined with the
commitment and
passion of our team,
reect our belief in
an “other side of
possible” approach
to our challenges
and our work.
