PharmD Postdoctoral Fellowship Program

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1 Novartis Institutes for Biomedical Research and Massachusetts College of Pharmacy and Health Sciences, Worcester/Manchester PharmD Postdoctoral Fellowship Program

2 Introduction Fellowship training in the Pharmaceutical Industry setting is an exciting opportunity for you as PharmD graduates to increase your knowledge of current and future therapeutics. It is also an excellent way to expand career options and to distinguish yourself among your peers. As a member of our drug development team, you will receive training in many areas including clinical pharmacology, drug metabolism and disposition, clinical study design, data analysis and other key fields of drug development. At Novartis, our goal is to discover and develop innovative products to prevent and cure diseases and improve patients quality of life. If you share the passion for this goal, then our Novartis Fellowship Program can provide the training and experience for you to pursue this as a career. Novartis is committed to educating and inspiring the next generation of scientists building the talent pool not only for Novartis, but the future leaders for the entire healthcare field. Successful and enduring partnerships with academia are one of the pillars of our approach. This Fellowship is a new opportunity that the Novartis Institutes for BioMedical Research (NIBR) is offering at our headquarters in Cambridge, MA, in collaboration with Massachusetts College of Pharmacy and Health Sciences (MCPHS). Our program is designed to provide you with the highest quality and standard of training and will give you the opportunity to apply your academic background to the drug development process. We are looking for highly motivated candidates who want to make a difference in people s lives as well as to build upon the knowledge obtained in Pharmacy School. Timothy M. Wright, MD Global Head, Translational Sciences Novartis Institutes for BioMedical Research

3 NIBR & MCPHS PharmD Fellowship Program Purpose The Novartis Institutes for BioMedical Research (NIBR) & Massachusetts College of Pharmacy and Health Sciences (MCPHS) Fellowship is a two year PharmD postdoctoral fellowship program designed to provide highlymotivated candidates the unique opportunity to gain practical experience in translational medicine and early clinical drug development at the Novartis Institutes for BioMedical Research. The Fellowship also presents the opportunity to increase academic skills in collaboration with Massachusetts College of Pharmacy and Health Sciences. Collectively, the Fellowship is designed to provide a comprehensive, high-quality post-doctoral experience. Goal The goal of the new Fellowship is to provide a qualified candidate with the training and experience to become a highly skilled clinical research scientist and to foster professional growth, enhancing the potential for a successful career in the pharmaceutical industry. Objectives During this program, the Fellow will: Gain extensive, practical experience in the drug development process and learn how to function as an integral part of a drug development team Utilize his/her clinical and scientific knowledge in the design and conduct of numerous Phase I clinical research studies Enhance his/her skill set through attendance and participation in didactic, clinical and small group forums related to clinical research as well as optional advanced coursework and seminars Expand his/her technical writing and presentation skills by publishing a manuscript and presenting data at a national research conference

4 Novartis Institutes for BioMedical Research (NIBR) Clinical Sciences & Innovation (CS&I) NIBR Overview The Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis committed to discovering innovative medicines to treat diseases with high unmet medical need. With more than 5,000 scientists and physicians around the world, our open and entrepreneurial culture encourages collaboration as we work to push the boundaries of science to change the practice of medicine. Research at NIBR begins and ends with the patient. Recent scientific advances, such as the completion of the human genome sequence and the scale-up of massive parallel experimentation, provide vast amounts of new information. Our challenge now is to interpret mechanistic and molecular-level information in the context of human physiology and network biology in order to discover new medicines. To meet this challenge, NIBR takes a multi-faceted approach: Scientifically, we strive to push the frontiers at the intersection of chemistry, biology, and medicine, and combine traditional approaches to pharmaceutical discovery with emerging concepts from the chemical and biological sciences. At the clinical/research interface our translational medicine experts inform our discovery research, provide a smooth transition from research to the clinic, and enable potential medicines to be tested more effectively in man.

5 Organizationally, we have created an open, collaborative, and exciting work environment. We encourage activities across geographical, cultural, and institutional barriers, as well as close collaboration with academia and biotech companies. A worldwide biotechnology hub, the Cambridge location of the NIBR headquarters puts us close to multiple renowned academic institutions and in the midst of one of the world s most impressive pools of scientific talent. The NIBR Cambridge site is home to research and translational sciences in oncology, ophthalmology, diabetes, infectious diseases, musculoskeletal disorders, and cardiovascular conditions. Within the Translational Sciences department of NIBR, Clinical Sciences & Innovations (CS&I) is responsible for the conduct of Phase I and Phase IIa clinical studies to 1) profile the safety, tolerability, pharmacokinetics and pharmacodynamics of novel compounds in humans, and 2) demonstrate clinical efficacy in Proof-of-Concept trials. There is no greater privilege than to work towards bettering human health, and no more exciting arena in which to do so than through discovery of new medicines. Mark Fishman President, NIBR

6 Fellowship Overview This new two-year NIBR Fellowship, sponsored by the CS&I department, provides the Fellow with practical experience in conducting early clinical drug development in an immersive pharmaceutical research environment. The Fellow may be exposed to a number of fundamental early clinical research studies such as first-in-human, proof-of-concept, dose escalation, pharmacokinetic drug-interaction and mechanistic profiling studies during the course of the Fellowship. In addition to early phase clinical research, the Fellow will also gain insight into the multi-disciplinary aspects of the drug development process. Specific responsibilities of the Fellow will include: development and review of study protocols, informed consent and case record forms; development of essential regulatory documents; understanding and maintaining compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements; selection and initiation of study centers; coordination of all operational aspects of conducting clinical trials; and analysis of study data and preparation of final study reports. The Fellow will routinely participate in meetings with experts who will be reviewing the scientific and operational aspects of a clinical trial. He or she may also have the opportunity to participate in meetings with external expert panels as well as contribute to an Investigational New Drug (IND) application the process which allows clinical testing to begin in humans. The Fellow also may be called upon to contribute to a New Drug Application (NDA) the regulatory process which is the final step leading to the approval of a new drug. The scope of work will allow the Fellow to work within international teams and to interact with different departments within Translational Sciences and the greater Novartis group, for example Biomarker Development (BMD), Drug Metabolism and Pharmacokinetics (DMPK), Preclinical Safety (PCS), Translational Medicine (TM), Biomedical Statistics, Technical Research and Development (TRD) and Drug Regulatory Affairs (DRA). The Fellow will be encouraged to identify and develop special projects of interest and will have the opportunity to attend at least one national scientific meeting annually. Furthermore, a variety of internal NIBR seminars and scientific courses designed to build scientific and professional skills will be available to the Fellow, both from the perspective of individual learning, and participation as course faculty.

7 NIBR Fellowship Leadership Team Nicole Weissbach, MSc. Pharm Fellowship Director Regional Manager Cambridge Clinical Sciences & Innovation My vision for this new Fellowship partnership between NIBR and MCPHS is to provide Fellows with a comprehensive overview and hands-on experience in the exciting world of translational medicine and early phase clinical development. Jamie Hutchinson, MA Fellowship Group Lead CS&I Clinical Trial Leader Clinical Sciences & Innovation The collaboration between NIBR and MCPHS is one in which I am proud to be involved. Both institutions are committed to providing an outstanding educational experience while preparing Fellows for future involvement in the pharmaceutical industry. Aaron Huang, PharmD Fellowship Advisor Clinical Trial Leader Clinical Sciences & Innovation The NIBR and MCPHS Fellowship program will allow you to learn the technical and communication skills to successfully design and execute early phase clinical trials skills that are valuable and marketable to all facets of pharmaceutical industry. Kiran Dole, PharmD Fellowship Advisor Clinical Trial Leader Clinical Sciences & Innovation The NIBR and MCPHS Fellowship program is an exciting opportunity to learn the fundamentals of early drug development in an accelerated manner with hands on experience. As a bonus, because the program is in its inception stages, the Fellow will have the unique opportunity to participate in the shaping of this new NIBR and MCPHS Fellowship. W. Ross Tracey, PhD Fellowship Advisor Associate Director Education Office I m excited about this opportunity for the Fellow and NIBR colleagues to share with each other their scientific knowledge, insights, and experiences, from which both stand to benefit. Not only will this interaction prepare the Fellow for a challenging career in the pharmaceutical industry, but also it stands to enhance pharma/academia collaborations, and help novel medicines reach patients in need.

8 Massachusetts College of Pharmacy and Health Sciences, Worcester/Manchester (MCPHS-W/M) Educational Mission Fellowship programs at the Massachusetts College of Pharmacy and Health Sciences, Worcester/Manchester (MCPHS-W/M) are established to provide high-quality, post-graduate educational opportunities for motivated individuals seeking advanced exposure to academics in addition to daily immersion in the biopharmaceutical industry. Rapid growth and interest in perpetuating our Fellowship programs requires special care to ensure quality, strength and continued development. Fellows will gain experience in the areas of teaching and research by participating in various courses and research with Faculty preceptors or other Faculty with mutual interest in selected research topics. MCPHS Worcester-Manchester Campuses Massachusetts College of Pharmacy and Health Sciences provides a unique academic environment to guide and support students toward a successful, sustainable career and leadership in healthcare. As a private independent institution with a long distinguished history of specializing in health sciences education, the College offers many programs that embody teaching excellence, active scholarship and research, professional service and community outreach. Furthermore, the College embraces a set of core values that reflect commitment to preparing competent, caring, ethical health professionals and scientists to meet the need for quality health care and cutting-edge knowledge. Massachusetts College of Pharmacy and Health Sciences are committed to providing the Fellow with distinctive teaching and educational experiences in a college setting and the opportunity to expand the depth and scope of their pharmacy related research skills. Activities at MCPHS-W/M balance the Fellowship by providing the Fellow with a research experience from an academic perspective.

9 As an adjunct assistant professor at the Massachusetts College of Pharmacy and Health Sciences Worcester/Manchester (MCPHS W/M), the Fellow will have the opportunity to: develop, coordinate, and teach courses at the Worcester campus; co-precept students on advanced experiential rotations; create and publish scholarly research and/or review articles; present data at professional meetings; and attend and participate in development seminars with other Fellows and residents from MCPHS-affiliated programs. MCPHS W/M faculty will precept and mentor the Fellow throughout the two years. This will be done in collaboration with the NIBR Fellowship director and staff. MCPHS W/M Faculty Michael Malloy, PharmD Professor and Dean Massachusetts College of Pharmacy and Health Sciences School of Pharmacy Worcester/Manchester I am excited that the Massachusetts College of Pharmacy is provided the opportunity to welcome NIBR as partner to our Industrial Fellowship program. We are developing a first-class fellowship by combining the history of success and resources offered through NIBR along with a focused plan for mentorship of our new fellow. Our work with NIBR will build a long-term partnership and create a unique fellowship embodying the best both institutions have to offer. My vision is that the success of this fellowship will be repeated through future fellowship opportunities between NIBR and the School of Pharmacy. Valerie Coppenrath, PharmD, BCPS Assistant Professor of Pharmacy Practice Massachusetts College of Pharmacy and Health Sciences School of Pharmacy Worcester/Manchester My primary role as pharmacist is education. I educate patients how to take medications safely and effectively, and I teach pharmacy students how to approach and solve drug-related problems. I also teach health care providers how to translate drug information into patient care. In this Fellowship, it is my goal to teach the Fellow how to teach. Determining the best way to convey information and facilitate learning is an important skill that will be a valuable asset in any area of pharmacy practice.

10 Application Process and Eligibility Requirements Program Design Duration: Two Years Location: Novartis Institutes for BioMedical Research, Cambridge, MA and Massachusetts School of Pharmacy, Worcester, MA Number of positions: One Start Date: July 1 Eligibility The Fellow 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. Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career in the biopharmaceutical industry. Certificate of Completion MCPHS-W/M and NIBR will award a certificate upon successful completion of the fellowship program. Compensation The fellow will receive a competitive stipend and benefit package, including comprehensive health insurance. Attendance to one or more professional meetings, conferences or workshops will be sponsored by NIBR. Application Interested individuals are invited to electronically submit a letter of interest, curriculum vitae, three letters of recommendation and an official college transcript to the address below. Participation in the ASHP Midyear Clinical Meeting/PPS is strongly encouraged, but not required. Applications may be submitted between November 15 and December 31 to the address below. Early submission is highly encouraged due to the competitive nature of the Fellow selection process. All correspondence should be sent to: Kate Brohm Massachusetts College of Pharmacy and Health Sciences 19 Foster Street Worcester, MA

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