Medicare Part D Elena Chan PharmD candidate, UCSF Tiffany Jew PharmD, MBA candidate, USC.
MULTIDISCIPLINARY PHARMD FELLOWSHIP...Using science to turn insights into medicine • Founded in...
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Denmark Netherlands United States Japan UNIVERSITY OF THE SCIENCES Key Program Features Academic Component • Appointment to Adjunct Clinical Instructor in Pharmacy Practice at USciences, Philadelphia College of Pharmacy • Completion of the Teaching and Learning Curriculum (TLC), which involves developing an ACPE-accredited Continuing Education presentation and engaging in small group teaching Professional Development • Attend meetings and congresses to engage in professional networking and provide support for Fellowship recruitment • Participate in professional development workshops, project leadership, and mentoring activities Scholarly Activity (optional) • Participants are eligible to enroll, tuition-free, in the online MBA in Pharmaceutical and Healthcare Business or various certificate programs offered through the University • Collaborate with faculty on an Institutional Review Board approved research project APPLICATION PROCESS AND ELIGIBILITY Application Process Interested candidates must submit a formal application through USciences, which includes: • Letter of intent • Curriculum vitae • Writing sample • Three references • Unofficial college transcript(s) Table of Contents ABOUT GENMAB Company Overview • Who We Are • Purpose • Pipeline • Core Values and Company Culture UNIVERSITY OF THE SCIENCES Program Overview • Program History Key Program Features • Academic Component • Professional Development • Scholarly Activity MULTIDISCIPLINARY PHARMD FELLOWSHIP Fellowship Overview Fellowship Objectives Multidisciplinary Rotations • Global Medical Affairs • Global Regulatory Affairs • Clinical Development APPLICATION PROCESS AND ELIGIBILITY ABOUT GENMAB Company Overview ABOUT GENMAB Who We Are Using science to turn insights into medicine • Founded in 1999 in Copenhagen, Denmark, Genmab is an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer • Our proprietary product pipeline and next-generation antibody technologies are the result of our strong company culture and a deep passion for innovation • We are inspired by nature and the power of the immune system to transform cancer treatment ABOUT GENMAB Purpose Combating cancer through the power of human antibodies Our core purpose is to improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products. It is our reason for being. Pipeline Our product pipeline consists of 21 antibodies in clinical development, including 3 marketed products, as well as ~20 in-house and partnered pre-clinical programs. UNIVERSITY OF THE SCIENCES Program Overview Program History • Founded in 2007, the Pharmaceutical Industry and Education Fellowship Program at University of the Sciences (USciences) provides Doctor of Pharmacy (PharmD) graduates with hands-on experiential training within the pharmaceutical industry • The Fellowship program currently partners with industry-leading companies to provide Fellows the opportunity to leverage their clinical knowledge in a corporate setting • Approximately 50 Fellows have completed the program at USciences, most of whom are continuing their careers in the industry setting Global reach: four locations ABOUT GENMAB Core Values and Company Culture By finding and retaining passionate, dedicated, supportive, and trustworthy people, we are confident that Genmab will continue to be a respected leader in the biotechnology industry. We pride ourselves on our ability to foster a strong company culture that drives us to be the best that we can be. • Passion for innovation • Determination—being the best at what we do • Integrity—we do the right thing • We work as one team and respect each other MULTIDISCIPLINARY PHARMD FELLOWSHIP Fellowship Objectives Cultivate future leaders in the biotechnology industry by helping to sharpen the skills needed for a successful career. Fellows will: • Gain a deep understanding of the roles and responsibilities across different functional areas by engaging in personalized rotational experiences • Establish therapeutic expertise • Develop familiarity with rules and regulations of the pharmaceutical industry Back to top MULTIDISCIPLINARY PHARMD FELLOWSHIP Working together to engineer a transformative tomorrow Actively recruiting two Fellows for 2021–2023 Back to top Back to top Back to top Back to top Back to top Click to learn about Genmab’s history Click to view our product pipeline 2015 2020 2019 2018 2016 2017 “On behalf of University of the Sciences, I would like to thank you for your interest in our Fellowship program! Industry Fellowship programs through University of the Sciences provide Fellows with outstanding educational opportunities, including professional development programming and options to pursue certificates or a master’s degree. I invite you to consider joining our team and wish you the best of luck during the application process.” James M. Hollands, PharmD, BCPS Director, Industry and Education Fellowship Programs at University of the Sciences Vice Chair and Associate Professor of Clinical Pharmacy “The Genmab Fellowship Program can be the needed conduit to open doors to a rewarding career in the pharmaceutical industry. You will be provided with an opportunity to fine-tune your transferable skills across multiple functions throughout this unique but challenging experience.” Jane Oreper, PharmD Associate Director, Global Medical Information Multidisciplinary Fellowship Coordinator Kruti Patel, RPh Director, Global Regulatory Affairs Preceptor for the Global Regulatory Affairs Rotation “Genmab, with its strong scientific focus and a growing biotech culture, provides a unique environment to candidates who are looking to become leaders within the pharmaceutical industry. We, at Genmab, are excited to provide you with this experience and empower the start of this journey towards your professional future.” Yasir Nagarwala, MD Vice President and Head, Global Medical Affairs Back to top Back to top MULTIDISCIPLINARY PHARMD FELLOWSHIP Multidisciplinary Rotations Genmab’s 2-year Fellowship program provides multidisciplinary training, with four 6-month rotations across three functional areas: Global Medical Affairs, Global Regulatory Affairs, and Clinical Development Sri Ghatta, PhD Director, Clinical Research Scientist Preceptor for the Clinical Development Rotation Eligibility • USciences Fellows will be selected on a nationally competitive basis • Applicants must have a PharmD degree from an ACPE-accredited school prior to the start of the Fellowship • Candidates must be a U.S. Citizen or Permanent Resident Learn more and apply Fellowship Experiences Deep experience across multiple functions Professional network Global biotechnology company Therapeutic expertise Innovative pipeline Leadership opportunities Supportive work environment Actively recruiting two Fellows for 2021–2023 In 2019, Genmab partnered with USciences to offer a unique one-year Fellowship in Global Medical Affairs Throughout the program, the Fellow is encouraged to gain a deep understanding of the science behind our innovative antibody technologies in the oncology space Our Fellowship provides an opportunity to be involved in pre-launch, launch, and post-launch activities across multiple functions with mentoring from experienced preceptors Genmab is expanding the Fellowship to two years and offering an opportunity to gain experience across multiple functions Global Medical Affairs Clinical Development Elective Rotation * Global Regulatory Affairs MULTIDISCIPLINARY PHARMD FELLOWSHIP Fellowship Overview Back to top Back to top *Fellows will have the opportunity to gain a deeper understanding in one of the functional areas for an additional 6 months. Click to hear from our CEO on why we put a premium on investing in people “I am thrilled about your interest in joining our Genmab team! This Fellowship provides a truly unique experience with unparalleled opportunities within the biotechnology industry. From the start of the Fellowship, I have been fully immersed in the team and have been able to take ownership of several projects. I am confident that my time here will contribute to my future success and long-term career goals. Are you ready to join our team of passionate and dedicated leaders at Genmab?” Rachel No, PharmD Fellow, Global Medical Affairs University of Michigan College of Pharmacy Fellowship Experiences Global Medical Information • Understand the role and responsibilities of a Global Medical Information professional in the pharmaceutical industry • Provide timely and balanced responses to Genmab external customers • Create and maintain a database of Global Medical Information responses, including consistently evaluating opportunities to innovate the content format • Provide high-quality review of Promotional and Scientific Exchange Materials to ensure accuracy and appropriateness of content • Attend scientific congresses to provide support for Medical booths • Gather insights to identify communication needs or data gaps to drive Medical Strategy Medical Communication • Gain therapeutic proficiency of products within the Oncology Portfolio • Develop a global strategic publication plan collaborating closely with key stakeholders including Medical Strategy, Statistics, Medical Research Team, and Senior Leaders • Develop familiarity with publication principles and participate in the development of a publication deliverable (congress presentation, manuscript) • Assess and identify gaps with Field Medical Resources, collaborating with Medical Affairs Strategy Leads, Field Medical and vendors to create and revise Field Medical resources, including slide decks, frequently asked questions (FAQs), and training materials Congress Planning • Understand the congress planning process from identifying key sessions to developing summaries following conclusion of the meeting, while collaborating with a large cross-matrix team • Organize pre-congress training and dissemination of information • Contribute to the development of Scientific content for the Medical Affairs congress booth Global Medical Affairs Rotation The fundamental responsibility of Genmab Global Medical Affairs is to optimize experiences and outcomes for patients, physicians, and payers. Global Medical Affairs achieves this through the creation and dissemination of scientific data to support the value of Genmab products for all of our stakeholders. We take an ethical and transparent approach to ensure that we are acting in the best interest of the patients and are dedicated to bridging the gap from clinical development to bedside. Fellowship Experiences • Develop understanding of global regulations and guidance related to drug development • Support cross-functional product teams by offering expertise and strategic guidance on regulatory requirements for global drug development and market registrations • File and maintain IND applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) and CTAs • Acquire a working knowledge of international and country-specific requirements to support the conduct of global clinical studies • Gain an understanding on how to best conduct health authority meetings and prepare teams for effective regulatory interactions • Interface with internal and external stakeholders to ensure company compliance with all appropriate regulations and guidance • Collaborate cross-functionally with global colleagues and scientists, representing diverse backgrounds, knowledge, and expertise Global Regulatory Affairs Rotation Global Regulatory Affairs at Genmab is responsible for creating and implementing global strategies for expedited drug development by liaising with the internal and external partners. Effective regulatory support and management are key in all stages of drug development, including filing of investigational new drug (IND) applications, clinical trial applications (CTAs), as well as unique experiences including breakthrough therapy, PRIME designation requests, orphan drug applications, and other novel regulatory pathways. The Global Regulatory Strategy team leads the company’s business-critical relationships with the U.S. Food and Drug Administration (FDA) and other global regulatory agencies throughout the world, ensuring the continued success of our oncology products. Clinical Development Rotation The Clinical Development rotation provides Fellows with the opportunity to gain an understanding of the core competencies required for the Clinical Research Scientist and to build knowledge of the Clinical Drug Development process. Fellowship Experiences • Gain knowledge in Translational Medicine and Pharmacokinetics concepts, and clinical regulations, including International Conference on Harmonization (ICH) guidelines, and Good Clinical Practice (GCP) requirements • Achieve proficiency in understanding clinical research protocols • Develop technical writing skills by creating a mock abbreviated protocol • Support study execution by understanding the process of investigator calls, evaluating escalation of clinical questions and clinical data querying
Transcript of MULTIDISCIPLINARY PHARMD FELLOWSHIP...Using science to turn insights into medicine • Founded in...
Denmark Netherlands United States Japan
UNIVERSITY OF THE SCIENCES
Key Program FeaturesAcademic Component• Appointment to Adjunct Clinical Instructor in Pharmacy Practice
at USciences, Philadelphia College of Pharmacy
• Completion of the Teaching and Learning Curriculum (TLC), which involves developing an ACPE-accredited Continuing Education presentation and engaging in small group teaching
Professional Development• Attend meetings and congresses to engage in professional
networking and provide support for Fellowship recruitment
• Participate in professional development workshops, project leadership, and mentoring activities
Scholarly Activity (optional)• Participants are eligible to enroll, tuition-free, in the online
MBA in Pharmaceutical and Healthcare Business or various certificate programs offered through the University
• Collaborate with faculty on an Institutional Review Board approved research project
APPLICATION PROCESS AND ELIGIBILITY
Application Process Interested candidates must submit a formal application through USciences, which includes:
• Letter of intent
• Curriculum vitae
• Writing sample
• Three references
• Unofficial college transcript(s)
Table of ContentsABOUT GENMAB
Company Overview• Who We Are• Purpose• Pipeline• Core Values and Company Culture
UNIVERSITY OF THE SCIENCESProgram Overview• Program History
Key Program Features• Academic Component• Professional Development• Scholarly Activity
MULTIDISCIPLINARY PHARMD FELLOWSHIPFellowship OverviewFellowship ObjectivesMultidisciplinary Rotations• Global Medical Affairs• Global Regulatory Affairs• Clinical Development
APPLICATION PROCESS AND ELIGIBILITY
ABOUT GENMAB
Company Overview
ABOUT GENMAB
Who We Are Using science to turn insights into medicine• Founded in 1999 in Copenhagen, Denmark, Genmab is
an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer
• Our proprietary product pipeline and next-generation antibody technologies are the result of our strong company culture and a deep passion for innovation
• We are inspired by nature and the power of the immune system to transform cancer treatment
ABOUT GENMAB
Purpose Combating cancer through the power of human antibodiesOur core purpose is to improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products. It is our reason for being.
PipelineOur product pipeline consists of 21 antibodies in clinical development, including 3 marketed products, as well as ~20 in-house and partnered pre-clinical programs.
UNIVERSITY OF THE SCIENCES
Program Overview Program History• Founded in 2007, the Pharmaceutical Industry and
Education Fellowship Program at University of the Sciences (USciences) provides Doctor of Pharmacy (PharmD) graduates with hands-on experiential training within the pharmaceutical industry
• The Fellowship program currently partners with industry-leading companies to provide Fellows the opportunity to leverage their clinical knowledge in a corporate setting
• Approximately 50 Fellows have completed the program at USciences, most of whom are continuing their careers in the industry setting
Global reach: four locations
ABOUT GENMAB
Core Values and Company CultureBy finding and retaining passionate, dedicated, supportive, and trustworthy people, we are confident that Genmab will continue to be a respected leader in the biotechnology industry. We pride ourselves on our ability to foster a strong company culture that drives us to be the best that we can be.
• Passion for innovation
• Determination—being the best at what we do
• Integrity—we do the right thing
• We work as one team and respect each other
MULTIDISCIPLINARY PHARMD FELLOWSHIP
Fellowship ObjectivesCultivate future leaders in the biotechnology industry by helping to sharpen the skills needed for a successful career.
Fellows will:
• Gain a deep understanding of the roles and responsibilities across different functional areas by engaging in personalized rotational experiences
• Establish therapeutic expertise
• Develop familiarity with rules and regulations of the pharmaceutical industry
Backto top
MULTIDISCIPLINARY PHARMD FELLOWSHIPWorking together to engineer a transformative tomorrow
Actively recruiting two Fellows for 2021–2023
Back to top
Back to top
Back to top
Back to top
Back to top
Click to learn about Genmab’s history
Click to view our product pipeline
2015
2020
2019
2018
2016
2017
“On behalf of University of the Sciences, I would like to thank you for your interest in our Fellowship program! Industry Fellowship programs through University of the Sciences provide Fellows with outstanding educational opportunities, including professional development programming and options to pursue certificates or a master’s degree. I invite you to consider joining our team and wish you the best of luck during the application process.”
James M. Hollands, PharmD, BCPS Director, Industry and Education Fellowship Programs at University of the Sciences Vice Chair and Associate Professor of Clinical Pharmacy
“The Genmab Fellowship Program can be the needed conduit to open doors to a rewarding career in the pharmaceutical industry. You will be provided with an opportunity to fine-tune your transferable skills across multiple functions throughout this unique but challenging experience.”
Jane Oreper, PharmD Associate Director, Global Medical Information Multidisciplinary Fellowship Coordinator
Kruti Patel, RPh Director, Global Regulatory Affairs
Preceptor for the Global Regulatory Affairs Rotation
“Genmab, with its strong scientific focus and a growing biotech culture, provides a unique environment to candidates who are looking to become leaders within the pharmaceutical industry. We, at Genmab, are excited to provide you with this experience and empower the start of this journey towards your professional future.”
Yasir Nagarwala, MD Vice President and Head, Global Medical Affairs
Back to top
Back to top
MULTIDISCIPLINARY PHARMD FELLOWSHIP
Multidisciplinary Rotations
Genmab’s 2-year Fellowship program provides multidisciplinary training, with four 6-month rotations across three functional areas: Global Medical Affairs, Global Regulatory Affairs, and Clinical Development
Sri Ghatta, PhD Director, Clinical Research Scientist
Preceptor for the Clinical Development Rotation
Eligibility• USciences Fellows will be selected on a nationally
competitive basis
• Applicants must have a PharmD degree from an ACPE-accredited school prior to the start of the Fellowship
• Candidates must be a U.S. Citizen or Permanent Resident
Learn more and apply
Fellowship Experiences
Deep experienceacross multiple
functions
Professionalnetwork
Global biotechnology
company
Therapeuticexpertise
Innovativepipeline
Leadershipopportunities
Supportive workenvironment
Actively recruiting two Fellows for 2021–2023
In 2019, Genmab partnered with USciences to offer a unique one-year Fellowship in Global Medical Affairs
Throughout the program, the Fellow is encouraged to gain a deep understanding of the science behind our innovative antibody technologies in the oncology space
Our Fellowship provides an opportunity to be involved in pre-launch, launch, and post-launch activities across multiple functions with mentoring from experienced preceptors
Genmab is expanding the Fellowship to two years and offering an opportunity to gain experience across multiple functions
Global Medical Affairs
Clinical Development
Elective Rotation*
Global Regulatory
Affairs
MULTIDISCIPLINARY PHARMD FELLOWSHIP
Fellowship Overview
Back to top
Back to top
*Fellows will have the opportunity to gain a deeper understanding in one of the functional areas for an additional 6 months.
Click to hear from our CEO on why we put a premium on investing in people
“I am thrilled about your interest in joining our Genmab team! This Fellowship provides a truly unique experience with unparalleled opportunities within the biotechnology industry. From the start of the Fellowship, I have been fully immersed in the team and have been able to take ownership of several projects. I am confident that my time here will contribute to my future success and long-term career goals. Are you ready to join our team of passionate and dedicated leaders at Genmab?”
Rachel No, PharmD Fellow, Global Medical Affairs University of Michigan College of Pharmacy
Fellowship Experiences
Global Medical Information• Understand the role and responsibilities of a Global Medical Information
professional in the pharmaceutical industry
• Provide timely and balanced responses to Genmab external customers
• Create and maintain a database of Global Medical Information responses, including consistently evaluating opportunities to innovate the content format
• Provide high-quality review of Promotional and Scientific Exchange Materials to ensure accuracy and appropriateness of content
• Attend scientific congresses to provide support for Medical booths
• Gather insights to identify communication needs or data gaps to drive Medical Strategy
Medical Communication• Gain therapeutic proficiency of products within the Oncology Portfolio
• Develop a global strategic publication plan collaborating closely with key stakeholders including Medical Strategy, Statistics, Medical Research Team, and Senior Leaders
• Develop familiarity with publication principles and participate in the development of a publication deliverable (congress presentation, manuscript)
• Assess and identify gaps with Field Medical Resources, collaborating with Medical Affairs Strategy Leads, Field Medical and vendors to create and revise Field Medical resources, including slide decks, frequently asked questions (FAQs), and training materials
Congress Planning• Understand the congress planning process from identifying key sessions
to developing summaries following conclusion of the meeting, while collaborating with a large cross-matrix team
• Organize pre-congress training and dissemination of information
• Contribute to the development of Scientific content for the Medical Affairs congress booth
Global Medical Affairs RotationThe fundamental responsibility of Genmab Global Medical Affairs is to optimize experiences and outcomes for patients, physicians, and payers. Global Medical Affairs achieves this through the creation and dissemination of scientific data to support the value of Genmab products for all of our stakeholders. We take an ethical and transparent approach to ensure that we are acting in the best interest of the patients and are dedicated to bridging the gap from clinical development to bedside.
Fellowship Experiences• Develop understanding of global regulations and guidance related to
drug development
• Support cross-functional product teams by offering expertise and strategic guidance on regulatory requirements for global drug development and market registrations
• File and maintain IND applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) and CTAs
• Acquire a working knowledge of international and country-specific requirements to support the conduct of global clinical studies
• Gain an understanding on how to best conduct health authority meetings and prepare teams for effective regulatory interactions
• Interface with internal and external stakeholders to ensure company compliance with all appropriate regulations and guidance
• Collaborate cross-functionally with global colleagues and scientists, representing diverse backgrounds, knowledge, and expertise
Global Regulatory Affairs Rotation Global Regulatory Affairs at Genmab is responsible for creating and implementing global strategies for expedited drug development by liaising with the internal and external partners. Effective regulatory support and management are key in all stages of drug development, including filing of investigational new drug (IND) applications, clinical trial applications (CTAs), as well as unique experiences including breakthrough therapy, PRIME designation requests, orphan drug applications, and other novel regulatory pathways. The Global Regulatory Strategy team leads the company’s business-critical relationships with the U.S. Food and Drug Administration (FDA) and other global regulatory agencies throughout the world, ensuring the continued success of our oncology products.
Clinical Development RotationThe Clinical Development rotation provides Fellows with the opportunity to gain an understanding of the core competencies required for the Clinical Research Scientist and to build knowledge of the Clinical Drug Development process.
Fellowship Experiences• Gain knowledge in Translational Medicine and Pharmacokinetics concepts, and
clinical regulations, including International Conference on Harmonization (ICH) guidelines, and Good Clinical Practice (GCP) requirements
• Achieve proficiency in understanding clinical research protocols
• Develop technical writing skills by creating a mock abbreviated protocol
• Support study execution by understanding the process of investigator calls, evaluating escalation of clinical questions and clinical data querying
