AstraZeneca Pharmaceutical Industry Fellowship Program 2022 - Rutgers Institute for Pharmaceutical Industry Fellowships
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AstraZeneca Pharmaceutical Industry Fellowship Program 2022 Rutgers Institute for Pharmaceutical Industry Fellowships 1
A Message from our Executive Sponsors On behalf of AstraZeneca and the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, we would like to thank you for your interest in our fellowship program. Our partnership with the Rutgers Institute for Pharmaceutical Industry Fellowships allows us to participate in the growth and development of the next generation of industry-based pharmacists. As a global biopharmaceutical company, AstraZeneca provides innovative medicines for some of the world’s most serious diseases. Pioneering new scientific ideas means never settling for second best and always being ready to challenge the status quo. That’s why we look for people who share our thirst for knowledge, our love of innovation, and our ambitious approach to self-improvement. If that’s you, why not discover everything that makes us a destination of choice for some of the brightest people in the global biopharmaceutical industry? We value the talents and skills of our 65,000 employees in more than 100 countries. Our people strategy, which supports our strategic priority of being a great place to work, is built around four key pillars: build and develop organizations and capabilities; develop a strong and diverse pipeline of leaders; drive a vibrant, high-performing culture; and generate a passion for people development. This means we place emphasis on effective leadership, the acquisition and retention of great talent, setting clear targets, open lines of communications, excellent learning and development opportunities, and a healthy, safe and energizing workplace – within a performance culture in which diversity is valued and individual success depends solely on personal merit and performance. Your fellowship experience at AstraZeneca will yield a broad overview of key functions within the biopharmaceutical industry through real-world experiences and learnings. You will have the opportunity to engage with dedicated professionals who are pushing the boundaries of science to deliver life-changing medicines. From all of us at AstraZeneca, we wish you much success and hope you strongly consider the AstraZeneca Fellowship Program as an investment in your personal career development and growth. 2
About AstraZeneca Our Purpose and Values Our values guide everything we do and underpin the delivery of our Global Scorecard targets. We Follow the Science • I am curious and push the boundaries of science • I am creative in how I work with partners and collaborators We Put Patients First Pascal Soriot, CEO • I am proud to serve patients and consider them in every decision I take • I strive to understand patients’ needs and act accordingly We Play To Win • I am determined to make the right choices to win • I build high performing teams that collaborate across the enterprise We Do The Right Thing • I am accountable for my actions and the success of AZ • I speak up to ensure that all we do is aligned to our values We Are Entrepreneurial • I am brave, resilient and take smart risks • I act with urgency and simplify the way work gets done 3
Available AstraZeneca Fellowship Positions Gaithersburg, MD (Greater DC Area) • US Marketing, Immuno-Oncology • US Marketing, ADC Oncology • Global Patient Safety, Oncology • Global Regulatory Labeling Strategy • Oncology Regulatory Science and Strategy (ORSS), Global Regulatory Affairs • Medical Information & Medical Affairs Strategy, Breast Cancer Wilmington, DE (Greater Philadelphia Area) • Medical Information & Medical Affairs Strategy, Respiratory Biologics • Medical Information & Medical Affairs Strategy, Renal 4
Current Fellows (2nd Year) Rija Saleem, Amanda Cline, Kara Glover, PharmD PharmD PharmD Medical Information/Medical Medical Information/Medical Medical Information/Medical Strategy, CVMD Strategy, Renal Strategy, Oncology University of Charleston Thomas Jefferson University Florida A&M Mivielis Rivera, Anthony Corry, Sheri Saka, PharmD, RPh PharmD, RPh PharmD Medical Information/Medical Global Patient Safety, Oncology Global Regulatory Affairs, Strategy, Oncology Temple University Oncology University of North Texas University of Toledo Madelaine Ambrose, Jon Apple, Stacy Ndubuizu, PharmD, RPh PharmD PharmD US Antibody Drug Congjugate HEOR, Oncology Global Labeling Strategy Marketing, Oncology University of Florida Mercer University Purdue University Medical Affairs US Marketing Regulatory and Safety 5
Current Fellows (1st Year) Carl Lowe, Ananya Murali Daniel Streng PharmD PharmD PharmD Medical Information/Medical Oncology Regulatory Strategy and Patient Advocacy, US Oncology Science Liaison/Medical Affairs Sciences (ORSS) University of Arizona Strategy, Respiratory University of Washington University of Mississippi Daniel Wong Sheena Dupuy PharmD PharmD Medical Information/Medical Access Strategy, US Oncology Affairs Strategy, Immuno- University of Florida Oncology Howard University Medical Affairs US Marketing Regulatory and Safety 6
Current Fellows (1st Year) Jennifer Huang, Morine Abdelmeseh Trace Wilkinson PharmD PharmD PharmD US Patient Safety Medical Information/Medical Promotional Regulatory Affairs, Florida A&M University Strategy, CVMD Oncology/CVMD California Northstate University St. John’s University Stefan Eapen Zulikhat Segunmaru PharmD PharmD Medical Information/Medical Health Economics and Outcomes Strategy, Oncology Research, Oncology Albany College of Pharmacy and Howard University Health Sciences Medical Affairs US Marketing Regulatory and Safety 7
Fellowship Steering Committee Andrew Fariello, PharmD Kevin Krause Vice President, Global Medical VP Strategy and Operations – Medical Capabilities, Oncology Business Unit Pharmaceuticals Executive Sponsor Executive Sponsor Jose Argueta, PharmD Alex Schuster, PharmD Corey Fang, PharmD Director of Medical Alignment, Oncology Senior Marketing Manager, Oncology Senior Medical Information Manager, Cardiovascular 8
Available Fellowships US Marketing - Immuno-Oncology Overview The Immuno-Oncology Pharmacy Fellow will be responsible for the strategic planning and tactical execution of initiatives focused on Improving Multi-Disciplinary Team coordination. Fellow’s responsibility will be to ensure that long term patient care plans are followed and to ensure the best possible outcomes for patients living with lung cancer. Fellowship Details The fellow will be a key member of the immuno-oncology marketing team and work in close partnership with marketing colleagues across the entire Immuno-Oncology franchise as well as the broader oncology business unit. This position is based at our Gaithersburg, MD campus, headquarters for our US Oncology Length: 2 years business, as well as the US Commercial Center for multiple Therapeutic Areas of our Global Product and Location: Gaithersburg, MD Portfolio Strategy businesses. Positions: 1 Objectives • Learn both the clinical and business elements of US franchise marketing in the immuno-oncology space • Develop new assets through innovation, collaboration with cross functional partners, and ownership through the Medical/Legal Review process • Key areas of focus will include, multi-disciplinary coordination focusing on Pharmacists, Nurse/Nurse Navigators, In-hospital IO Initiation, and improving duration of therapy through adverse event management and care team coordination. • Build strategic and tactical plans for future IO indications or new launches pending data 10
Available Fellowships US Marketing – Antibody-Drug Conjugates Oncology Overview The fellow will spend most of their time supporting the US ADC oncology franchise marketing team and has the opportunity to pursue additional projects with other cross-functional teams, depending on personal goals. Fellowship Details Fellowship Objectives: • Learn both the clinical and business elements of US franchise marketing in the Length: 2 years ADC space, across tumor types Location: Gaithersburg, MD • Develop new assets through innovation, collaboration with cross functional Positions: 1 partners, and ownership through the medical, legal, regulatory review process • Build strategic and tactical plans for future indications in AstraZeneca’s oncology portfolio 11
Available Fellowships Global Patient Safety - Oncology First Year Objectives: The target is to develop the fellow’s core competencies and leadership capabilities in global patient safety. Throughout the fellowship period, the fellow will be given the opportunity to be involved in the following: • Gain an understanding on the foundation of pharmacovigilance activities and key roles for global patient safety colleagues • Support routine pharmacovigilance activities including signal detection, authoring of periodic reports Fellowship Details and core safety documents, contribution to safety strategy for early and late development products • Ability to reference and apply key pharmacovigilance guidelines use in production of core PV Length: 2 years documents • Gain a deep understanding of the Safety Strategy and Management Team Lead (SSaMTL) role and Location: Gaithersburg, MD key responsibilities within this position Positions: 1 • Other activities as discussed and agreed with the line manager / preceptor / mentor Second Year Objectives: Build on competencies gained in year 1 to: • Lead pharmacovigilance activities for an early development product(s) as a SSaMTL • Lead safety contribution in coordination with the GSP for health authority interactions and/ or submission activities • Contribute to process improvement activities within the global patient safety and patient safety center of excellence organizations • Collaborate with cross functional teams to lead safety contribution and strategy • Attend a major Oncology area related conference to obtain relevant disease state and safety knowledge in support of Global Patient Safety teams • Be provided rotational opportunities in other functional areas such as Chemistry Manufacturer and Control (CMC), Global Medical Affairs (GMA), Clinical Development, Global Regulatory Affairs and Global Labeling Group (GLG) knowledge 12
Available Fellowships Global Regulatory Labeling Strategy First Year Objectives: The target is to develop the fellow’s core competencies and leadership capabilities in strategic labeling development. Throughout the fellowship period, the fellow will be given the opportunity to be involved in the following: • Gain an understanding of the labeling development process, the end-to-end labeling lifecycle, and the role of the Global Labeling Strategist Fellowship Details • Support project teams and Global Labeling Strategist(s) with important labeling precedence for strategic decision-making Length: 2 years • Enhance written and verbal communication skills • Opportunities to be proficient in project management at the anticipated level Location: Gaithersburg, MD • Other activities as discussed and agreed with the line manager / preceptor Positions: 1 Second Year Objectives: Build on competencies gained in Year 1: • Become proficient in understanding and applying labeling-related regulations and guidance for the US and EU, and concepts related to the Core Data Sheet • Build necessary competencies to effectively lead Product Labeling Teams (PLTs) in the development and/or maintenance of high-quality Core Prescribing Information, EU Quality Review Documents (EU QRDs), US Prescribing Information (USPIs), Patient Package Inserts (PPIs), Medication Guides (MGs), and Instructions for Use (IFUs) • Build regulatory intelligence and analysis skills in support of labeling brand differentiation strategy • Interact with colleagues from various departments to learn about the contributions of key stakeholder functions to labeling activities • Be provided rotational opportunities in other functional areas such as Global Medical Affairs (GMA), Patient Safety (PS) and Global Regulatory affairs. • Build competencies in leadership, negotiation skills, relationship and consensus building, critical information seeking, and multi-cultural awareness and sensitivity 13 • Provide mentorship to junior staff (toward the end of the fellowship)
Available Fellowships Oncology Regulatory Science and Strategy (ORSS) Global Regulatory Affairs First Year Objectives: The target is to develop the fellow’s core competencies and leadership capabilities in regulatory affairs. Throughout the fellowship period, the fellow will be given the opportunity to be involved in the following: • Gain experience with operational and strategic aspects of global oncology regulatory affairs Fellowship Details • Support project teams and Global Regulatory Lead (GRL) with important regulatory precedent for strategic decision-making • Opportunities to be proficient in project management at the anticipated level Length: 2 years • Provide mentorship to junior staff (toward the end of his fellowship) Location: Gaithersburg, MD • Other activities as discussed and agreed with the line manager / preceptor / mentor Positions: 1 Second Year Objectives: •Build on competencies gained in year 1 to: • Learn key aspects of global regulations to apply regulatory requirements to the development, approval, and maintenance of drugs and biologics • Gain experience in developing regulatory strategy • Participate in health authority interactions and assess regulatory risks • Work with Regulatory Project Management to execute and manage the end-to-end delivery of regulatory submissions for global clinical trials • Work with matrix team members to identify solutions that meet regulatory requirements as well as commercial objectives • Be provided rotational opportunities in other functional areas such as Chemistry Manufacturer and Control (CMC), Global Medical Affairs (GMA), Clinical Development, Patient Safety (PS) and Global Labeling Group (GLG) knowledge • Attend a major Oncology area or Regulatory Affairs related conference to obtain relevant disease state knowledge and regulatory science updates in support of ORSS teams • Gain exposure to interactions between ORSS, other R&D and non-R&D functions 14
Available Fellowships Medical Information & Medical Affairs Strategy, Breast Cancer First Year Objectives: • Provide balanced scientific responses to unsolicited requests from healthcare professionals, and internal and external customers regarding AstraZeneca products and adverse event and Product Quality Control (PQC) reporting, including both US & Global Fellowship Details • Research medical literature, evaluate scientific data and develop evidence-based medical content in standard responses, slide decks, FAQs etc. • Responsible for medical review of advertising and promotional material to ensure scientific accuracy, Length: 2 years regulatory, and commercial objectives Location: Gaithersburg, MD • Participate in collaborative projects with Marketing, Training, other Medical Affairs functions, including Positions: 1 Global, and Sales to provide scientific support and education to various medical and sales teams • Participate scientific congress activity (materials, attendance, medical information booth, disease information and competitive insights etc.) • Gain an understanding of the laws, regulations, and policies required to help ensure legal and ethical interactions with health care professionals Second Year Objectives: • Develop understanding of medical affairs activities and functions, including medical strategy and execution, launch planning, and congress strategies. • Participate in strategic planning and execution based on medical unmet need based on perspective of patients, providers and payers • Participate in medical strategy execution through engagement with medical affairs cross functional teams including field medical/medical payer, medical information, health outcomes, and medical education grants office • Interact with other AZ departments to gain understanding of how these functions inform medical affairs activities (marketing, global medical, clinical development, legal, regulatory) 15
Available Fellowships Medical Information and Medical Strategy— Respiratory Biologics Overview This fellow will be an integral part of the team, gain hands-on experience and will be trained and developed to manage responsibilities similar to those in current full-time positions within AZ. This 2-year fellowship will have a MI functional focus with a strong Medical Strategy and execution component within the Respiratory Biologics and Inhaled Therapeutic Area. First Year - Medical Information Objectives: Fellowship Details • Develop an understanding of global and local medical strategy development and execution as it related to MI deliverables • Research medical literature and evaluate scientific data to develop evidence-based medical global and US content (i.e., standard responses, slide decks, FAQs) Length: 2 years • Provide balanced scientific responses to unsolicited requests from healthcare professionals, and internal and external Location: Wilmington, DE customers regarding AZ products • Responsible for medical review of advertising and promotional material to ensure scientific accuracy, regulatory and Positions: 1 commercial objectives • Collaborative projects with Marketing, Training, other Medical functions and Sales to provide scientific support and education to various medical and sales teams • Participate in scientific congress activity (materials, attendance, medical information, disease information and competitive insights etc.) • Gain an understanding of the laws, regulations and policies required to help ensure legal and ethical interactions with health care professionals Second Year - Medical Affairs Strategy Objectives: • Develop an understanding of the US medical strategy development and execution within Respiratory Biologics Program • Participate in medical strategy execution through engagement with field medical, medical information, publication strategy, medical education, health policy, and outcomes teams • Participate in strategic/launch planning based on the unmet medical needs from the perspectives of patients, providers, and payers • Interact with marketing, clinical development, global medical, legal, and regulatory affairs as they relate to US Medical daily activities and special projects (e.g., advisory boards, congress planning, vendor management) • Gain practical experience in providing information to external and internal stakeholders that enhances the appropriate use of AZ’s products by responding to customer inquiries with balanced scientific information and delivering scientific information that clinically differentiates AZ’s products. 16 • Learn about standard internal processes and regulatory/compliance requirements as well as developing expertise in disease state management, emerging therapies and the competitive landscape
Available Fellowships Medical Information and Medical Affairs Strategy— Renal Overview • Complete all required Compliance Training • Complete Renal Disease and Product training • Successfully complete Prescribing Information assessment and/or verbal product certification • Demonstrates continuous professionalism and respect Fellowship Details • Positive and cooperative attitude- willing to take on new projects to help others and learn all aspects of the function • Develop networking/relationship building skills to connect with individuals across all of AstraZeneca’s cross-functional Length: 2 years teams (including AZ functional leads and other AZ fellows) and the Rutgers fellowship community Location: Wilmington, DE Medical Information (MI) Objectives: Positions: 1 • Provide fair-balanced scientific responses to unsolicited requests from healthcare professionals in the US and develop global documents for local market use regarding AstraZeneca products • Research medical literature and evaluate scientific data to develop evidence-based medical content in standard responses (including verbal), slide decks, and other Medical Affairs materials (including payor assets such as AMCP dossier) • Perform medical review of advertising and promotional material to ensure scientific accuracy • Develop scientific content, including slide decks and other resources such as medical Q&As, to support the field in Medical Affairs • Participate in collaborative projects with Marketing, other Medical Affairs functions, and Sales to provide scientific support and education to various field medical and sales teams on product and disease state knowledge • Participate in scientific congress activities, including materials development and Medical Information booth staffing Medical Affairs (MA) Strategy Objectives: • Assist with development and execution of congress and insight strategy • Understand the role of a medical communications agency for MA activities • Participate in execution of medical strategy through engagement with field medical, medical information, scientific training, medical education, promotion regulatory affairs and payer evidence teams as they relate to US Medical Affairs activities 17
Rutgers Pharmaceutical Industry Fellowship Program History INSTITUTE FOR FOUNDING PHARMACEUTICAL In 1984, at Rutgers, The State University of INDUSTRY FELLOWSHIPS New Jersey, the Ernest Mario School of In 2002, Dr. Ernest Mario generously provided an endowment to Pharmacy and two pharmaceutical establish the Institute for Pharmaceutical Industry Fellowships companies began a collaborative pilot to enhance and promote the role of pharmacists in industry through program to evaluate the potential the RPIF Program. The Institute staff members: contributions of clinically-trained pharmacists • Provide leadership and administrative support; within a pharmaceutical industry practice • Promote quality, communication, and scholarly activity; and setting. Following the successful pilot, the • Arrange specialized fellowship training opportunities within the Rutgers Pharmaceutical Industry Fellowship pharmaceutical and biopharmaceutical industry. (RPIF) Program grew significantly and expanded to include 21 companies within the In 2018, our program expanded to offer interdisciplinary fellows’ pharmaceutical and biopharmaceutical training by adding select physician fellowship opportunities to our industry and approximately 300 Fellows. well-established program. FELLOWS More than 1,300 Post-Doctoral Fellows have completed the RPIF Program, most of whom are experiencing influential and rewarding careers in the LEADERSHIP pharmaceutical and biopharmaceutical industry throughout the US and The RPIF Program has thrived under the leadership abroad. The RPIF Program has Preceptors and Mentors from industry who of the founder, Dr. Joseph A. Barone, Dean and share their knowledge and experiences with the Fellows through an intense Professor II of the Ernest Mario School of Pharmacy, but closely-guided training program. Assignments and projects are Dr. Carolyn Seyss, the Director for the Institute for challenging, meaningful, and designed to enhance understanding of the Pharmaceutical Industry Fellowships, and Dr. pharmaceutical and biopharmaceutical industry and the Fellow’s functional Michael Toscani as Director Emeritus. area(s). Our goal is to provide the environment for Fellows to build the foundations for their careers as future leaders in the industry. 18
About the Rutgers Component Professional Development Series All Fellows gather once monthly as a group to participate in the Professional Development Day (PDD) series, an important component of their training that complements the hands-on experience provided at the partner companies. The PDDs are steered by a committee of Fellows and are designed to enhance the Fellows’ leadership skills such as emotional intelligence, communication, critical decision making, and presentation skills. Fellows develop skill sets under the guidance of external trainers. PDDs also provide general knowledge about various aspects of drug development/commercialization and issues facing the pharmaceutical and biopharmaceutical industry and promote connectivity and a sense of community among Fellows and alumni from different companies and disciplines. The Fellows can learn from each other through individual and group presentations and debates on topics and issues related to the pharmaceutical and biopharmaceutical industry. The dynamic forum of PDD provides an opportunity for open discussion and debate among fellows, Rutgers faculty, and company Preceptors. In addition, outside experts provide training and professional development in a variety of areas (e.g., tools for corporate success; professional writing, presentations, meeting facilitation, negotiating, influencing, networking, and conflict resolution skills; giving and receiving feedback; and business and dining etiquette). Other PDD guest speakers include senior industry executives, patient advocacy groups, and successful RPIF Program alumni who share their insights and experiences. Importantly, PDDs provide an excellent opportunity for Fellows to interact with each other and develop lasting personal friendships and a strong professional network of Fellows, faculty, alumni, and other industry executives. 19
Key Program Features The Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growth and development of future pharmaceutical and biopharmaceutical industry professionals and Rutgers, The State University of New leaders through the following key program features: Jersey, with over 71,000 students in its three campuses, is one of the major Family of Leading Companies–Partners include several of the top global state university systems in the United F pharmaceutical and biopharmaceutical companies. States. The New Jersey College of Pharmacy was founded in 1892 and was incorporated into the University in 1927. The Ernest Mario School of Outstanding Alumni Track Record–Over 1,300 alumni hold prominent positions O at many leading companies. Pharmacy is part of Rutgers Biomedical and Health Sciences, the only state school of pharmacy in New Jersey, with approximately 1,350 students in its Strong Network—Fellows develop valuable, lasting connections with each other, S alumni, Preceptors, and faculty. Doctor of Pharmacy degree program. The Rutgers Ernest Mario School of Pharmacy is located on the University’s main science and technology campus Trusted and Proven Since 1984 — the Rutgers Fellowship Program is nationally T recognized, trusted, and proven as the key pathway to industry for pharmacists in Piscataway, New Jersey. Because of its relationship with and, for most, close as future leaders proximity to the nation's leading pharmaceutical and biopharmaceutical Enhanced Career Development – Breadth of experiences informs career path companies, the Ernest Mario School of E choices and increasingly challenging assignments build depth of experience, Pharmacy and the RPIF Program are enhancing the potential for accelerated career paths. uniquely capable of providing fellows with advanced training in the Rigorous Academic Component–Rutgers affiliation provides academic and pharmaceutical and biopharmaceutical R professional development opportunities. industry. 20
Application Process and Eligibility Requirements Pharmacy Fellows for the Rutgers Pharmaceutical Industry Fellowship Program are selected on a nationally competitive basis. Candidates must have completed a Doctor of Pharmacy degree from an ACPE-accredited institution before July 1 of the fellowship term. How to Apply: Interviewing is conducted on a rolling basis. Interested candidates may submit their application and supporting materials (letter of intent, curriculum vitae, and three letters of recommendation) during October 2021 by visiting our website at: https://pharmafellows.rutgers.edu Joseph A. Barone, All application materials must be submitted electronically to the RPIF Website. Pharm.D., F.C.C.P. Dean and Professor II Required Items Deadline* Ernest Mario School of Pharmacy Curriculum Vitae (CV) November 1st Rutgers University Letter of Intent (LOI) November 1st 3 Letters of Recommendation December 5th Carolyn Seyss, Pharm.D. Fellowship Director and RPIF (LORs) Alumna *Candidates are considered on a rolling basis. Submission of materials prior to deadline is strongly Institute for Pharmaceutical encouraged. Industry Fellowships Ernest Mario School of Pharmacy Your Letter of Intent & Letters of Recommendation should be addressed to: Joseph A. Barone, Pharm.D., F.C.C.P. Dean and Professor II Michael Toscani, PharmD. Ernest Mario School of Pharmacy Research Professor, Fellowship Director Emeritus Rutgers, The State University of New Jersey Institute for Pharmaceutical Industry 160 Frelinghuysen Road Fellowships Piscataway, NJ 08854-8020 Ernest Mario School of Pharmacy 21
In Memory of Our Beloved Fellowship Program Founder, Debra S. Weintraub, Pharm.D. 22
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