biopharmaceutical industry pharmd fellowships€¦ · • curriculum vitae • unofficial college...

Biopharmaceutical Industry PharmD FellowshipsUnique Fellowships, Endless Opportunities

Introduction

A Message from Alfred Sandrock Jr., Executive Vice President and Chief Medical Officer..............2

About Biogen..........................................................................................................................3

About MCPHS University..........................................................................................................4

MCPHS University Faculty Preceptors........................................................................................4

About the Fellowships.............................................................................................................5

Eligibility and Application Procedure..........................................................................................6

Frequently Asked Questions..................................................................................................23

Fellowships

Regulatory Sciences/Safety and Benefit-Risk Management......................................................7

Safety and Benefit-Risk Management.......................................................................................9

Regulatory Sciences–Advertising and Promotion....................................................................11

Regulatory Sciences–Trial Master File/Clinical Trial Application..............................................13

Global Medical Writing...........................................................................................................15

Worldwide Medical................................................................................................................17

Global Regulatory Sciences...................................................................................................19

US Medical...........................................................................................................................21

Fellowship Alumni.................................................................................................................24

Table of Contents

A message from Al Sandrock Jr., MD, PhD | 2

A Message from Al Sandrock Jr.Executive Vice President and Chief Medical Officer

Dear Prospective Biogen Fellow,

Thank you for your interest in the Biogen Post-PharmD Fellowship Programs. The growing biopharmaceutical industry provides tremendous opportunity for pharmacists looking for an alternative and diverse career. Since the start of this fellowship, Biogen, in collaboration with MCPHS University, has trained and promoted the role of the Doctor of Pharmacy within the company, academia, and the industry as a whole. Fellows completing this program grow professionally, in terms of skills and expertise, and have substantially impacted programs integral to the success of Biogen.

Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases. Our culture of innovation, inclusiveness, and empowerment creates an atmosphere of learning and cultivates new opportunities for our employees and fellows. Our passion and focus goes beyond improving the lives of patients and extends to supporting the local community, nurturing science education for students of every age, and maximizing our environmental sustainability.

We are at an exciting time at Biogen and are committed to pursuing science that truly matters. Best of luck as you explore the different opportunities available to you, and I strongly encourage you to consider the Biogen Fellowship.

Sincerely,

Al Sandrock Jr., MD, PhD Executive Vice President and Chief Medical Officer

3 | About Biogen

About BiogenCaring Deeply. Working Fearlessly. Changing Lives.™

At Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.

Millions of people around the world are affected by Multiple Sclerosis, Alzheimer’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis (ALS). Many people also suffer from less common diseases such as Spinal Muscular Atrophy (SMA) and Progressive Supranuclear Palsy (PSP). We believe that no other disease area holds as much need or as much promise for medical breakthroughs as neuroscience.

Biogen has some of the world’s best neurologists and neuroscientists. We engage with physicians and scientific leaders around the world with the aim to further medical research. Our focus on neuroscience, our deep scientific expertise, and our courage to take risks make us leaders in the research and development of medicines to transform neuroscience to benefit society.

Our technology and engineering capabilities create novel ways to seamlessly transition products from development to manufacturing with the intent of bringing our high-quality medicines to market faster. We respect the contributions of health care providers caring for people living with neurological diseases. We honor the important role of caregivers, families, and friends who care about them.

Biogen is committed to working with advocacy and patient organizations as they serve the communities they represent.

Recognizing the challenges facing health care systems today, we collaborate with regulatory authorities and customers such as health care providers and payers, so that those in need can access our medicines.

Professional, ethical, and compliant, we hold ourselves accountable to deliver value to our shareholders. Biogen contributes to the communities where we live. We are committed to our employees, diversity and inclusion, and environmental sustainability.

We care deeply about making a difference.

We work fearlessly. We do not give up even when challenged, pursuing innovation in all that we do.

We are humbled by the opportunity to change lives.

About MCPHS University | 4

About MCPHS UniversityMCPHS University provides an academic environment to guide and support fellows toward a successful career in the biopharmaceutical industry. As a private institution with a history of specializing in the health sciences, MCPHS University offers programs that embody scholarship, professional service, and community outreach.

Through MCPHS University, the fellow will have the opportunity to gain teaching and research experience in an academic setting. Throughout the program, MCPHS University faculty and company program leaders mentor fellows according to each fellow’s scholarly and professional interests.

As an adjunct assistant professor at MCPHS University, each fellow may have the opportunity to

• develop, coordinate, and teach pharmacy courses.

• co-precept students on advanced experiential rotations.

• create and publish scholarly research and review articles.

• present data at scientific and clinical meetings.

• participate in professional development seminars.

MCPHS University Faculty Preceptors

Michael Steinberg, BA, BS, PharmD, BCOP Professor of Pharmacy Practice

Catherine Taglieri, BSP, PharmD, RPh Assistant Professor of Pharmacy Practice

Kristine Willett, PharmD, FASHP Associate Professor of Pharmacy Practice

Amee Mistry, PharmDAssociate Professor of Pharmacy Practice

Brian Rittenhouse, MS, PhDPharmaceutical Business and Administrative Sciences

Paul Kaplita, PhDAssociate Professor of Pharmaceutical Sciences

Michael Angelini, PharmD, BCPPAssociate Professor of Pharmacy Practice

Timothy Aungst, PharmDAssistant Professor of Pharmacy Practice

5 | About the Fellowships

About the FellowshipsBiogen, in collaboration with MCPHS University, offers 8 unique fellowship programs to promote the role of Doctor of Pharmacy (PharmD) within the biopharmaceutical industry:

• Regulatory Sciences/Safety and Benefit-Risk Management (Reg/SABR)

• Safety and Benefit-Risk Management (SABR)

• Regulatory Sciences–Advertising and Promotion (Reg–AP)

• Regulatory Sciences–Trial Master File/Clinical Trial Application (Reg–TMF/CTA)

• Global Medical Writing (GMW)

• Worldwide Medical (WWM)

• Global Regulatory Sciences

• US Medical

Fellows will gain extensive experience through a variety of practical activities in both industry and academic settings, which will enhance the potential for accelerated career development.

Eligibility & Application Procedure | 6

EligibilityThe MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis, with interviews at the American Society of Health Systems Pharmacists (ASHP) Midyear meeting.

• Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy at thecommencement of the program.

• Candidates must have strong written and verbal communication skills and a strong interest in pursuing a careerwithin the biopharmaceutical industry.

• All candidates must have authorization to work in the United States throughout the duration of the one ortwo-year fellowship. No visa sponsorship will be provided.

Application ProcedureBefore ASHP Midyear Clinical Meeting Registration is required with the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting Personnel Placement Service (PPS) to interview at Midyear. In addition, to be scheduled for an interview at the ASHP Clinical Midyear Meeting, applicants must upload the following application materials to the online portal (www.mcphs.fluidreview.com/) by November 26th, 2018:

• Letter of intent

• Curriculum vitae

• Unofficial college transcript

• Contact information of three references for letters of recommendation.

After ASHP Midyear Clinical Meeting Three letters of recommendation must be submitted by the three references provided no later than December 10, 2018.

Onsite Interviews Top candidates will be invited for onsite interviews at the sponsoring company’s location. Final candidates will be required to go through additional screening and onboarding as required by MCPHS University.

Elective OptionsThe fellow will have the opportunity to spend up to 4 months in another department within Biogen.

Departments may include, but are not limited to:

• Clinical Drug Supply Chain

• Global Clinical Operations

• Global Commercial Strategy

• Health Economics and Outcomes Research

• Marketing

Also, the fellow will have the opportunity to precept PharmD students.

7 | Regulatory Sciences/Safety and Benefit-Risk Management

Regulatory SciencesRegulatory Sciences is a well-integrated global department that provides worldwide strategic regulatory guidance and operational support for Biogen’s development and commercial programs. The fellow will acquire a better understanding of the dynamics of the drug development process throughout the life cycle of our products, from early development through approval and commercialization.

During the rotation in Regulatory Sciences, the fellow will have the opportunity to gain experience in the different functions of the regulatory department, which are as follows:

• Global Regulatory Policy

• Early Global Regulatory Sciences (EGRS)

• Late Global Regulatory Sciences (LGRS)

• International Regulatory Sciences

• US Regulatory Sciences (USRS)

• Clinical Trial Applications (CTA)

• Global Regulatory Information and Operations

Safety and Benefit-Risk Management (SABR)Biogen is responsible for the continuous assessment of the benefit-risk relationship of all of its products— starting in the early stages of development and continuing through the postmarketing phase. Members of the SABR department are continuously working to gain a better understanding of the safety profile of marketed products and those in development, in order to provide the medical community and patients with the data necessary to make an informed decision regarding disease management.

During the rotation in SABR, the fellow will have an opportunity to rotate through 3 general areas:

• Global Case Management

• Pharmacovigilance (PV) Scientists

• Epidemiology

Regulatory Sciences/Safety and Benefit-Risk Management Fellowship

REGULATORY SCIENCES

10 months

4 months

ELECTIVE

2-YEAR PROGRAM

[email protected]

Fellowship Contact Information

Regulatory Sciences/Safety and Benefit-Risk Management | 8

“The SABR/Regulatory Fellowship provides the opportunity for Fellows to gain a well-rounded experience through exposure and practical experience across multiple functions. They become integral members of our teams.”

Sharon Chan, PharmDSenior Manager, SABR

“The Biogen fellowship programs have been a source of incredibly talented and inspiring individuals who have contributed to the recognition of the programs throughout the company.”

Stacie Knight Director, Regulatory Sciences

“Fellowship programs within Biogen provide so much more than experience in the pharmaceutical industry. These fellowships provide opportunities to make an impact by working with talented teams on meaningful projects to achieve patient-centered goals.”

Patsy Casalino, PharmDMCPHS University - Boston

”As a first-year fellow in Regulatory Sciences/Safety and Benefit-Risk Management, I enjoy the privilege of working on projects that have a meaningful impact on the company. The fellowship program provides the perfect transition between student and professional: While fellows are expected to be independent and self-motivated, they are also offered support from a close-knit network of co-fellows, as well as guidance from highly experienced industry professionals. I feel confident that this experience will equip me with the proper knowledge, skills, and attributes to excel in a career in either functional area.”

Lori Yeterian, PharmDMCPHS University - Boston

Program Directors

Second-Year Fellow

First-Year Fellows

Regulatory Sciences/Safety and Benefit-Risk Management Fellowship

10 months

4 months

ELECTIVE

SAFETY AND BENEFIT-RISK MANAGEMENT

2-YEAR PROGRAM

“The Regulatory Sciences/Safety and Benefit-Risk Management Fellowship offers numerous opportunities for fellows to collaborate cross-functionally with experienced professionals on meaningful projects within unique therapeutic areas. This fellowship program fosters development of the skills necessary for a successful transition to a career in the biopharmaceutical industry.”

Amanda Hall, PharmDTemple University, School of Pharmacy

GLOBAL CASE MANAGEMENT

10 months



• Regulatory Sciences

• Global Medical Writing

• Clinical Drug Supply Chain





4 months

ELECTIVE

9 | Safety and Benefit-Risk Management

About Safety and Benefit-Risk Management Biogen is responsible for the continuous assessment of the benefit-risk relationship of all of its products—starting in the early stages of development and continuing through the postmarketing phase. Members of the Safety and Benefit-Risk Management department are continuously working to gain a better understanding of the safety profile of marketed products and those in development in order to provide the medical community and patients with the data necessary to make an informed decision regarding disease management.

This 2-year Safety and Benefit-Risk fellowship is designed to provide an in-depth and hands-on experience. Starting from individual case safety reports through aggregate reporting the fellow will learn about the pharmacovigilance life cycle. Through this program, the fellow will gain exposure to the following three general areas:

Global Case Management: During this rotation, the fellow will become knowledgeable about the adverse event reporting process including initial review and triage, adverse event report assessment, and distribution rules. The fellow will also enhance his or her understanding of clinical trial safety, ICSR reporting, global pharmacovigilance regulations and guidelines, safety data exchange agreements, and vendor oversight.

Epidemiology: During this rotation, the fellow will work closely with epidemiologists to provide REMS support, understand and evaluate real-world data, and prepare epidemiology-based product summaries

Pharmacovigilance (PV) Scientists: During this rotation, the fellow will engage in safety surveillance activities and prepare and review signal evaluations, periodic safety update reports, and risk management plans utilizing the training and skills gained through previous rotations.

Safety and Benefit-Risk Management Fellowship 2-YEAR PROGRAM

[email protected]


10 months

4 months

ELECTIVE

PHARMACOVIGILANCE/EPIDEMIOLOGY

Safety and Benefit-Risk Management | 10

“The SABR Fellowship allows the Fellow to learn and contribute to the pharmacovigilance lifecycle through rotations across the various sub-functions. They become integral members of our teams.”

Sharon Chan, PharmD Senior Manager, SABR

Program Director

Safety and Benefit-Risk Management Fellowship 2-YEAR PROGRAM

“As a second-year fellow at Biogen, I feel fortunate to have the opportunity to be directly involved in various cross-functional projects. The team within SABR is fully supportive of the fellowship and is invested in our professional development. I look forward to the continued professional growth throughout the program, which will prepare me for a successful career in the biopharmaceutical industry.”

Michael Ryan, PharmDMCPHS University - Boston

“I am incredibly grateful to have the opportunity to work closely with passionate and accomplished professionals on valuable projects impacting challenging disease states. Biogen provides a challenging yet encouraging environment to drive personal and professional growth through the guidance of experienced preceptors and colleagues.”

Shrinal Patel, PharmDMCPHS University - Boston

Second-Year Fellow

First-Year Fellow



• Worldwide Medical



• Safety and Benefit-Risk Management



11 | Regulatory Sciences–Advertising and Promotion

About Regulatory Sciences–APRegulatory Sciences–Advertising and Promotion (AP) is one of the functional groups within the Regulatory Sciences organization that support Biogen’s development and commercial programs. The Regulatory Sciences–AP team is responsible for providing Biogen with strategic, high-quality, timely, and decisive regulatory advice on advertising and promotional materials, communications, and company activities in accordance with FDA regulations, company policies, and business goals. The AP group leads communications with regulatory agencies related to US advertising and promotion.

This 2-year Regulatory Sciences–AP fellowship is designed to provide advanced, hands-on experience. The fellowship provides AP professionals with comprehensive knowledge of regulations and real-world applications for advertising and promotion in the biopharmaceutical industry.

Regulatory Sciences–AP is an area in which skills cannot be obtained solely from a professional degree; instead, the necessary knowledge is gained predominantly through on-the-job training and hands-on experience.

Biogen recognizes this critical need for experienced Regulatory Sciences–AP professionals and has partnered with the marketing department to offer a fellowship with opportunities to experience and learn the following:

• the FDA regulations that govern advertising,and promotion

• how to accurately and effectively apply regulationsand provide guidance

• how promotional materials are developed throughthe commercial organization

The overall goal of the program is to prepare each fellow to be a successful Regulatory Sciences–AP professional with a solid understanding of how FDA regulations are followed by the biopharmaceutical industry and enforced by the FDA. Upon completion of the fellowship, the experienced fellow will be well-prepared to enter into an advanced career in Regulatory Sciences–AP.

Regulatory Sciences–Advertising and Promotion Fellowship

REGULATORY SCIENCES–AP

9 months

3 months

US MARKETING

2-YEAR PROGRAM

[email protected]


“This fellowship program is an excellent opportunity to work closely with a team of passionate and experienced regulatory science professionals in the setting of advertising and promotion. The leadership within the advertising and promotion team has been amazing; with their direction and support I was able to quickly become a valuable, contributing member of the team. I am surrounded by a great group of mentors, who are devoted to seeing me grow personally and professionally, and I am confident that the unique opportunities provided to me during this fellowship will help me to be successful in the biopharmaceutical industry.”

Kathleen Neumann, PharmDMCPHS University - Boston

“Being a part of this fellowship program has given me a hands on approach into the world of advertising and promotion within regulatory sciences. The team values mentorship and has gone above and beyond to provide me with the fundamental understanding of advertising and promotion. I am so thankful to have the opportunity to work with a team that strives to make me feel among and provides me with all the tools I need to flourish in this field. I know that by the end of my fellowship I will be more than prepared to obtain a successful career in the biopharmaceutical industry.”

Adaku Onwuzurumba, PharmDMCPHS University - Worcester

Second-Year Fellow

First-Year Fellow

Regulatory Sciences–Advertising and Promotion | 12

“Our program provides individuals interested in the regulatory sciences with a unique opportunity to work in the constantly evolving field of advertising and promotion. Our well-structured fellowship allows for the opportunity to work on cross-functional teams, gain hands-on regulatory experience, and participate in rotations in both marketing and an elective of their choice. These opportunities, along with a core foundation in advertising and promotion, provide a well-rounded experience that allows our fellows to be competitive within the biopharmaceutical industry.”

Blythe BuchananDirector, Regulatory Sciences

Program Director

Advertising and Promotion Fellowship

3 months

9 months

REGULATORY SCIENCES–AP

ELECTIVE

2-YEAR PROGRAM









13 | Regulatory Sciences–TMF/CTA

About Regulatory Sciences–TMF/CTAThis fellowship will primarily focus on the Trial Master File (TMF) and Clinical Trial Application (CTA). Over the course of 2 years, the fellow will be a member of cross- functional teams and work with key individuals that have a comprehensive knowledge of regulatory requirements for the planning, conduct, and reporting of clinical trials. Maintenance of the accurate and appropriate documentation is needed for managing the conduct of clinical trials and enables evaluation by audit or inspection for Good Clinical Practices (GCP) compliance. The fellow will also have the opportunity to complete collaborative initiatives within Regulatory Sciences.

The TMF is considered the autobiography of a study and is our evidence that the integrity of the trial data, study analysis, and study conclusions are credible, and that patient rights and safety have been protected. During the first year of the fellowship, the fellow will obtain a functional working knowledge within the TMF group as a support system for the TMF Study Owners, Manager, and Process Owner. The team provides comprehensive collaborative opportunities with TMF partners such as Global Clinical Operations, Safety and Benefit Risk Management, and Records Management. This provides the foundation for the second year of the fellowship.

During the second year, the fellow will gain direct experience within the CTA team, which is responsible for managing international clinical trial applications with health authorities. In doing so, the team is responsible for the oversight of Clinical Research Organizations (CRO) and the collaboration with Biogen to ensure timely execution of the application submissions. As an integral member of the cross-functional study team which provides regulatory strategy for the studies, the fellow will support the CTA lead with startup, maintenance, and close-out activities for various studies. The team provides regulatory training and education to increase the fellow’s exposure to multiple aspects of Regulatory Sciences.

Regulatory Sciences–Trial Master File/Clinical Trial Application Fellowship

TRIAL MASTER FILE

2-YEAR PROGRAM

[email protected]


3 months

ELECTIVE

Regulatory Sciences–TMF/CTA | 14

Second-Year Fellow

First-Year Fellow

“The TMF/CTA fellowship provides a unique opportunity to really understand and take ownership of regulatory responsibilities, including the structure and maintenance of the Trial Master File. While working with core team members I feel supported and encouraged to learn and grow as much as possible during my time as a fellow.”

Olivia Weiss, PharmDNotre Dame of Maryland University, School of Pharmacy

“Biogen has an open and collaborative workplace culture, so everyone is easily approachable and willing to help with my professional development. The TMF and CTA teams have been very supportive, and working alongside them has exposed me to varied functions within R&D as well as working with CROs. I am thrilled to have this opportunity to gain such an invaluable experience.”

Edwin Addai, PharmDMCPHS University-Worcester

Trial Master File/Clinical Trial Application Fellowship

CLINICAL TRIAL APPLICATION

2-YEAR PROGRAM

“The TMF/CTA Regulatory fellowship offers a great opportunity for learning about the composition of the clinical trial master file and experience in execution of global clinical trial applications. Fellows will be exposed to a broad insight of regulatory processes on a global level and develop a thorough understanding of regulatory affairs within clinical trials.”

Matt StagrayAssociate Director, Regulatory Sciences

“The Biogen fellowship programs have been a source of incredibly talented and inspiring individuals who have contributed to the recognition of the programs throughout the company.”

Stacie Knight Director, Regulatory Sciences

Program Directors

3 months

ELECTIVE

Regulatory Sciences - Global Medical Writing Fellowship

15 | Global Medical Writing

About Global Medical Writing Biogen’s Medical Writing Fellowship will focus on clinical and regulatory documents needed for drug development. Over the course of 2 years, the fellow will work with teams including physicians, statisticians, clinical pharmacologists, and other scientists to create the documents needed to support the conduct and reporting of clinical trials, as well as the documents needed to obtain and maintain marketing authorization for therapies.

In the first year, the fellow will develop documents at the level of an individual clinical study of a potential new drug. These documents will include the clinical study protocol and the clinical study report needed to conduct and describe the data from the study, respectively. The fellow, as part of the cross-functional team of scientists and physicians, will learn about the purpose, structure and components of a protocol, and the process required to develop and adapt the protocol during the course of a study.

The fellow will also become familiar in the interpretation and reporting of the clinical data, the purpose of the clinical study report, and the importance of the data in this document to stakeholders.

Working within cross-functional teams provides exposure to the different scientific and medical functions within drug development and in how they collaborate on clinical studies. Also, developing an understanding of how the study-level documents are created will provide the fellow with the foundation needed to understand how individual studies support the overall drug development process.

In the second year, the fellow will work on program-level documents that are required to support all studies within a drug development program, or support the submission of data to regulatory authorities for marketing authorizations. This will allow the fellow to gain experience with a wider variety of documents and an understanding of their function within the broader context of drug development.

2-YEAR PROGRAM






• Scientific Communications


[email protected]


GLOBAL MEDICAL WRITING

10 months

4 months

ELECTIVE

Regulatory Sciences - Global Medical Writing Fellowship

Global Medical Writing | 16

2-YEAR PROGRAM

Program Directors

“Medical Writing offers a great vantage point to be involved in a wide range of activities that support drug development.”

Mark Fielding, PhD Director, Medical Writing

“The medical writing fellowship program offers a unique opportunity to gain knowledge on clinical development through the preparation of clinical and regulatory documents.”

Begona Ruiz Perez, PhD Director, Medical Writing

Second-Year Fellow

“The Global Medical Writing Fellowship offers the opportunity to learn about and be involved with every stage of the clinical development process. Fellows work with cross-functional teams to produce crucial clinical and regulatory documents. The program connects fellows with faculty at MCPHS and colleagues at the most influential biotech and pharmaceutical companies in the world.”

Jeffrey Roth, PharmDUNC Eshelman School of Pharmacy

First-Year Fellow

10 months

4 months

ELECTIVE

GLOBAL MEDICAL WRITING

“The Global Medical Writing Fellowship provides unique opportunities to become involved in the drug development process at Biogen. Fellows are exposed to a wide variety of projects and collaborate with cross-functional teams to produce key regulatory deliverables. The mentorship and experiences offered to fellows promote a thorough understanding of the strategy and documents required for regulatory submissions. This program builds a strong foundation for any pharmacist aspiring to work in the biopharmaceutical industry.”

Melissa Laracy, PharmD University of Connecticut School of Pharmacy

About Worldwide Medical Biogen Worldwide Medical’s (WM) mission is to inform real-world clinical practice and to optimize patient outcomes. We do this by leading medical expert engagement, phase 4 studies and real-world data generation efforts, scientific communications, medical information, and by providing support to Research and Development, Corporate Development, Commercial, and others. Worldwide Medical is also responsible for providing healthcare professionals, regulatory agencies, professional groups, and patients with the medical and scientific information they need to understand our company’s products and diseases of focus.

During the first year of the fellowship program, the fellow will have the opportunity to explore the different functional areas within Worldwide Medical. If desired, the fellow will have the opportunity to select a rotation outside of Worldwide Medical to obtain a unique perspective and understanding of the biopharmaceutical industry.

For the second year of the fellowship, the fellow will pick an area of concentration to prepare them for a career within the biopharmaceutical industry. The area of concentration must be within Worldwide Medical.

Worldwide Medical Fellowship

12 months

17 | Worldwide Medical

FUNCTIONAL GROUP ROTATIONS

2-YEAR PROGRAM

[email protected]


Worldwide Medical Fellowship

12 months

Worldwide Medical | 18

“The Worldwide Medical program calls upon driven individuals to immerse themselves in the Biogen culture of ingenuity, passion, and excellence, contributing to the fellows’ intellectual and professional growth.”

Kyle Terpak, PharmD Senior Manager, Global Scientific Communications

Program Director

CORE FUNCTIONAL GROUP

2-YEAR PROGRAM

“By offering a range of robust rotations in various functional areas within Medical Affairs, the Worldwide Medical fellowship program empowers fellows to lead impactful projects directed at improving clinical practice across Biogen’s core and emerging therapeutic areas.”

Tucker Ward, PharmDMCPHS University - Boston

First-Year Fellows

“The Worldwide Medical fellowship at Biogen gives fellows the opportunity to rotate through different functional areas and acquire a multitude of valuable experiences. This unique structure, along with the mentorship of experts who serve as preceptors, equips fellows with a strong and competitive foundation for a successful career within the biopharmaceutical industry.”

Stephanie Yin, PharmDUniversity of Texas at Austin, School of Pharmacy

Global Regulatory Sciences

19 | Global Regulatory Sciences

About Global Regulatory Sciences Regulatory Sciences at Biogen is an integral part of global development, providing strategic guidance to programs across the spectrum of development and commercialization. As a leader in neuroscience, Biogen encourages innovation across all aspects of drug development, including regulatory strategy. Regulatory Sciences at Biogen is continually looked to for new and risk-forward approaches. This spirit of pioneering is the ideal background for a PharmD fellow to challenge themselves and grow as a professional.

Fellows in this program will gain valuable hands-on experience working on programs that span the development lifecycle. By working directly with experienced regulatory professionals, fellows will learn the fundamentals of both US and global regulatory and form the foundation for a successful career in Regulatory Sciences. In addition, fellows may have the opportunity to work on department-wide initiatives that span multiple drug development programs.

Over the course of this two-year fellowship, the fellow will gain experience in three groups within Regulatory Sciences:

• United States Regulatory Sciences (USRS)

• Early Global Regulatory Sciences (EGRS)

• Late-stage Global Regulatory Sciences (LGRS)

2-YEAR PROGRAM

US REGULATORY SCIENCES

8 months

8 months

EARLY GLOBAL REGULATORY SCIENCES

Elective OptionsIn addition to these core functions, the fellow will have an opportunity to spend several months in an optional elective in another department within Biogen, either within regulatory or another functional area.


• Asset Management


• Regulatory Sciences–

Advertising and Promotion (AP)

• Global Regulatory Policy

• International Regulatory Sciences

[email protected]


Global Regulatory Sciences

Global Regulatory Sciences | 20

2-YEAR PROGRAM

8 months

8 monthsEARLY GLOBAL REGULATORY SCIENCES

LATE GLOBAL REGULATORY SCIENCES

“Biogen is simply the best place to grow, develop, and learn as a regulatory professional. As an intern, a fellow, and as an employee, Biogen has given me new challenges and new opportunities at each turn. I continue to learn every day in a supportive and innovative environment.”

Colin Gillis, PharmD Manager, Global Regulatory Sciences

Program Director

US Medical

3 months

9 months ELECTIVE

US MEDICAL DIRECTOR’S OFFICE

21 | US Medical

About US MedicalThe US Affiliate Office for Global Medical Affairs (“US Medical”) is responsible for high-quality medical engagement with US healthcare entities. It is staffed with pharmacists, physicians, and highly scientifically trained business professionals, and is organized to deeply engage three key segments of the US marketplace: (1) health care professionals (2) managed care and formulary decision makers, and (3) patient advocacy groups and professional societies. US Medical is currently responsible for medical engagement in various therapeutic areas including but not limited to Multiple Sclerosis, Spinal Muscular Atrophy, Alzheimer’s Disease, and Progressive Supranuclear Palsy.

The US Medical Fellowship is designed for fellows to acquire the skills necessary to drive scientific thought leadership, launch rare disease and specialty products, and enable market access to therapies.

During the fellowship within US Medical, the fellow will have the opportunity to undertake responsibilities such as:

• Developing and delivering disease state and product trainings

• Designing and executing real-world research projects

• Reviewing investigator-led research proposals

• Authoring scientific publications and value dossiers

• Attending scientific and managed care conferences to reportkey findings

• Engaging thought leaders and coverage decision makers

• Joining meetings with patient advocacy groups andprofessional societies

• Developing and reviewing promotional and marketingmaterials

• Assisting in planning of advisory board meetings

• Supporting product launches and asset divesting efforts

• Developing medical strategy for field team

• Interacting with US Commercial colleagues

Elective OptionsThe fellow will have the opportunity to spend up to 3 months rotating in at least two (2) other departments within Biogen, such as:

• US Marketing

• Global Medical Evidence and ResearchInnovation (MERI)

• Global Health Economics and OutcomesResearch

• US Pricing and Channel Distribution

• US Patient Services

• US Government Policy and Advocacy

2-YEAR PROGRAM

[email protected]


The US Medical Fellow will spend eighteen (18) months rotating within the US Medical Office, across functions responsible for medical engagement of health care professionals, payors and specialty pharmacies, and patient advocacy groups and professional societies. Fellows will be offered an opportunity to select a track based on their background and interests and following consultation with their Fellowship Directors.

By the end of the fellowship, the US Medical Fellow will have acquired skills and experiences to pursue roles within Medical Affairs or Market Access.

US Medical

3 months

9 months

MEDICAL VALUE STRATEGY & EXECUTION OFFICE

US Medical | 22

Program Directors

“The most competitive life sciences companies in the coming decade will be masters of real-world data and will excel at communicating scientific evidence. Above all, they will help consumers and constituents navigate a far more complex healthcare universe. The US Medical Fellowship is designed to train the next generation of business leaders so they can expertly steward clinicians and payors to make crisp, clear decisions using scientific evidence with confidence, so ultimately, patients living with neurological diseases have an opportunity for better outcomes.”

Michelle Patel Associate Director, Medical Value Strategy & Execution, US Medical Director

“Fellows who participate in our program will have an intense immersive experience into the inner workings of a leading affiliate in a global organization. My goal is to challenge fellows with short and medium-term projects, so they are well-suited to continue their career in the pharmaceutical industry.”

Jason Mendoza, PhD Medical Director, US Lead: TECFIDERA, Interferons, and BIIB098 (pipeline)

2-YEAR PROGRAM

ELECTIVE

23 | Frequently Asked Questions

Frequently Asked QuestionsWhat is the timeline for the fellowship selection process?

• Initial interviews for the fellowship are conducted at the ASHP Midyear Clinical Meeting. All candidates willneed to register with Personnel Placement Service (PPS) in order to interview.

• To request an interview, select the fellowship program(s) of interest through the PPS portal and provide yourcontact information and a copy of your CV.

• Applicants may submit their application materials before or after the ASHP Midyear Clinical Meeting.All application materials must be received by December 20th; however, applications will be accepted andreviewed prior to the due date. Due to the competitive nature of the selection process, applicants areencouraged to submit their application materials as soon as possible.

• The selection process will be complete by late January.

Do I need previous industry experience in order to be considered for the fellowship program?

• No, previous industry experience is not required, but it is beneficial.

Do I have to be a registered pharmacist to qualify for this fellowship?

• No, but licensure is strongly encouraged. To qualify for this fellowship, you must be a graduateof an ACPE-accredited PharmD program at the commencement of the fellowship.

Will I be able to defer my student loans?

• Yes, provided that the student loan company accepts fellowship deferment. Candidates should contact theirlender(s) for more information regarding eligibility and terms of deferment.

Can I apply for more than 1 fellowship at Biogen?

• Yes, we welcome potential applicants to explore all of the opportunities available at Biogen.

Is a cover letter required to request an interview at PPS?

• No, a cover letter is not needed for the initial interview request, but a letter of intent is required in theformal application.

Are there any other elective options available that are not listed?

• All elective options are subject to availability. Additional options may be available depending on interest.

Fellowship Alumni | 24

Fellowship Alumni

Hamdan Almas, PharmD University of California–San Francisco School of Pharmacy

Benjamin Exter, PharmD Northeastern UniversityBouvé College of Health Sciences

Raymond Kim, PharmDUniversity of California–San Francisco School of Pharmacy

James Scanlon, PharmDNortheastern University Bouvé College of Health Sciences

Amy Gangadharan, PharmDNortheastern University Bouvé College of Health Sciences

Stephanie Fradette, PharmDNortheastern University Bouvé College of Health Sciences

Desmond Murphy, PharmDNortheastern University Bouvé College of Health Sciences

Kimberly Price, PharmDMassachusetts College of Pharmacy and Health Sciences–Worcester

Lauren Oliva, PharmDRutgers University Ernest Mario School of Pharmacy

Theresa Foster, PharmDUniversity of New England College of Pharmacy

Martin Kwok, PharmDThe Ohio State University College of Pharmacy

Director, Oncology–US MarketingGILEAD Sciences, Inc.

Senior Director, Clinical SciencesUnum Therapeutics

Associate Director, Medical ServicesUltragenyx Pharmaceutical Inc.

Senior Regional Medical LiaisonAmgen

Director, Drug SafetyIovance Biotherapeutics, Inc.

Associate Medical Director, Clinical DevelopmentBiogen

Medical Science LiaisonAlnylam Pharmaceuticals

Senior Manager, Scientific Communicationsbluebird bio

Associate Director, Regulatory SciencesBiogen

Pharmacovigilance Scientist Ironwood Pharmaceuticals

Associate Director, Regulatory AffairsIronwood Pharmaceuticals

Regulatory Sciences–Safety and Benefit Risk Management

Alumnus/Alumna Current Position

20

07

– 2

00

92

00

8 –

20

102

00

9 –

20

112

010

– 2

012

20

12 –

20

142

013

– 2

015

20

14 –

20

16

Fellowship Alumni (Cont’d)2

01

6-2

01

8

Regulatory Sciences-Global Medical Writing

Jihae Lim, PharmDTemple University, School of Pharmacy

Joseph Naggar, PharmDMCPHS University-Boston

Medical WriterAthenex

Senior Specialist, Publication ManagementMerck

Regulatory Sciences-Safety and Benefit Risk Management2

013

– 2

015

20

15 –

20

17

Regulatory Sciences- Advertising and Promotion

Richard Lem, PharmDRutgers University Ernest Mario School of Pharmacy

20

12 –

20

14

Sheila Kundu, PharmDUniversity of the Sciences Philadelphia College of Pharmacy

Kate Ho, PharmDPurdue University College of Pharmacy

Associate Director, Regulatory Affairs Advertising and PromotionBayer

Senior Manager, Regulatory Sciences Advertising and PromotionBiogen

Manager, Regulatory AffairsAdvertising and PromotionTESARO, Inc

Colin Gillis, PharmDNortheastern UniversityBouve College of Health Sciences

Tina Chhabra, PharmDVirginia Commonwealth UniversitySchool of Pharmacy

Bhumi Patel, PharmDUniversity of the SciencesPhiladelphia College of Pharmacy

Kathy Lu, PharmDUniversity of the SciencesPhiladelphia College of Pharmacy

Manager, Global Regulatory StrategyBiogen

ACCP/ASHP/VCU Congressional Healthcare Policy Fellow

Manager, Regulatory Global LabelingPfizer

Manager, Regulatory Global LabelingAmgen

20

15 –

20

172

016

– 2

018

20

16

-20

18

Regulatory Sciences-Trial Master File/Clinical Trial Application

April Nguyen, PharmDUniversity of the PacificThomas J. Long School of Pharmacy and Health Sciences

Manager, Regulatory SciencesBiogen

25 | Fellowship Alumni

Fellowship Alumni (Cont’d)Worldwide Medical

Jonathan Kendter, PharmDUniversity of the SciencesPhiladelphia College of Pharmacy

Manas Prasad, PharmDUniversity of Connecticut School of Pharmacy

Jinny Min, PharmDUniversity of Michigan College of Pharmacy

Melanie Standridge, PharmDThomas Jefferson University College of Pharmacy

Senior Regional Medical Liaison, Health Outcomes & Pharmacoeconomics SpecialistAmgen

Medical Information Specialist, Medical AffairsBiogen

Senior Manager, Medical CommunicationsRhythm Pharmaceuticals

Senior Manager, Medical InformationAstraZeneca

Real World Outcomes, Innovative Partnerships, and Insights

Jaanai Babb, PharmDRutgers University Ernest Mario School of Pharmacy

Payer Marketing ManagerSage Therapeutics

Fellowship Alumni | 26

20

12

– 2

01

42

01

3 –

20

15

20

16

– 2

01

82

01

6 –

20

18

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