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PharmDFellowship ProgramRGBIN PARTNERSHIP WITH2019 – 2021
Dear Prospective TESARO Fellow:On behalf of all associates at TESARO, we are delighted you are consideringjoining us for your fellowship. We are a group of nearly 800 associates acrossthe globe who are devoted to providing transformative therapies to patientsliving with cancer. Our associates have a dynamic mix of backgrounds andexperiences that when pulled together create a truly unique perspective andability to advance our mission on a global scale.When I first graduated with my pharmacy degree, I could not have imaginedwhere my professional journey would take me. My educational foundationhas proven instrumental in my ability to advance through the pharmaceuticalindustry and help thousands of individuals with life-threatening diseases. Thework you will get to do as a part of an industry team is vastly different anduniquely satisfying to what you could achieve elsewhere.At TESARO—taken from the Galician word for “hidden treasure”—we aim to be adifferent kind of biopharmaceutical company. When Dr. Mary Lynne Hedley, ourPresident & COO, and I founded this company in 2010, we wanted to focus onfinding those “hidden treasures” in drug development that others may overlook.This perspective has been central to our vision and ability to give new hope tothe patients we serve.Today, we continue to build a global oncology company anchored by ourfoundational products: ZEJULA, a once-daily oral medicine used for themaintenance treatment of women with recurrent ovarian, fallopian tube, orprimary peritoneal cancer; and TSR-042, our investigational anti-PD-1 inhibitor.With our robust pipeline we are investigating monotherapy, double- and tripledrug combinations across a range of gynecologic and lung cancers. This uniquestrategy will enable us to help more patients who need new treatment options.Our success, measured by the number of patients we serve, is the direct resultof our dedicated associates aligning with our mission and values, and actingwith a sense of urgency and responsibility. In return, TESARO is fully committedto developing our associates into superior leaders and ambassadors to thecancer community. We believe in bringing people together for the sharedpurpose of changing the lives of those living with cancer. If our story resonateswith you, I invite you to apply to our fellowship program and join us as weadvance our mission for the patients we serve.Lonnie MoulderCEO
CONTENTS4Company OverviewThe TESARO ValuesPipeline6Medical AffairsFellowship OverviewMedical Affairs Fellowship Team9Regulatory AffairsFellowship OverviewRegulatory Affairs Fellowship Team11Northeastern University Partnership12Life in Boston13Application Process
Company OverviewTESARO is a biopharmaceutical company devoted to providing transformativetherapies to people bravely facing cancer. We see new possibilities to responsiblydevelop and commercialize innovative treatments where others may not. Relationshipsare vital to the success of our business, and we are committed to being a trustedpartner to the cancer community.The TESARO ValuesThe PatientSustainabilityAudacious GoalsRelationshipsThe Whole Person14PharmD Fellowship Program 2019 – 2021
om, and Karen Ann’s descriptionsTESARO Product Pipelineadd a period after each sentenceCompoundTherapeutic AreaNiraparibPARP Inhibitor1L Ovarian Cancer Maintenance (PRIMA)Chemotherapy /- TSR-042(Anti-PD-1 mAb) & maintenanceniraparib /- TSR-042†1L Ovarian Cancer Treatment andMaintenance (FIRST)*NiraparibRecurrent Ovarian Cancer Treatment (4th lineor later) (QUADRA)Phase 1Phase 2Phase 3be consistent and appear as: 3Niraparib bevacizumab1L Ovarian Cancer Maintenance (OVARIO)Phase 1/2 Recurrent Ovarian Cancer(AVANOVA)*‡Niraparib TSR-042 bevacizumabPlatinum-resistant Ovarian Cancer Treatment(2nd or 3rd line) (OPAL)Niraparib TSR-042Advanced NSCLC (JASPER)h elective rotations may beNiraparibNeoadjuvant Treatment in HER2- andBRCAmut Breast CancerTSR-042Anti-PD-1 mAbMSI-H tumors (including metastaticendometrial cancer), MSS endometrialcancer and NSCLC (GARNET)TSR-022 Anti-TIM-3 mAb /- TSR-042Melanoma, NSCLC and CRC (AMBER)m Overview to: The fellow will joinill be in Regulatory Strategy, withn other regulatory functions andTSR-033 Anti-LAG-3 mAb /- TSR-042Various tumor types (CITRINO)*In collaboration with ENGOT, the European Network for Gynecological Oncological Trial groups; †bevacizumab may beincluded as part of the chemotherapy and maintenance regimen per local standard of care, ‡investigator sponsored trial,PARP: Poly ADP-ribose Polymerase; mAb: monoclonal antibody; NSCLC: non-small cell lung cancer; MSI-H: microsatelliteinstability high; MSS: microsatellite stable, CRC: colorectal cancer.TESARO /TEH-SAHR-OH/noun, origin: Galician1. treasure.bottom of page 9 and addect to fill the space?The company name, TESARO, comes from the Galician word “tesouro,”meaning treasure, and it embodies the company’s vision. TESAROassociates find opportunities that others may overlook in order to createvalue for patients, healthcare providers, and our investors.At TESARO, we strive to be the high-integrity, patient-focused partnerof choice in oncology. Patients are at the center of all that TESARO does,and they are the reason we act with a sense of urgency and passion.Mary Lynne Hedley, Ph.D., President & COOPharmD Fellowship Program 2019 – 20215
Global Medical Affairs (2 positions)Program Overview: The Medical Affairs Fellowship at TESARO is split into twocore teams: the Medical Information (1 position) and Medical Education & Training(1 position) teams. Within each fellow’s respective positions, dedicated teamresponsibilities will be assigned as you progress through the entire fellowship. Eachfellow will also have the opportunity to be immersed in all US and Global MedicalAffairs activities through core Medical Affairs rotations as well as have the opportunityto work cross-functionally through elective rotations.Medical InformationMedical TrainingPrimary Activities:Primary Activities:Medical Information contentdevelopment, including standardresponse letters, clinical trialhandouts, core data decks, andliterature summariesDevelop and maintain trainingmaterials related to disease state andclinical landscape for the TESAROproduct portfolio Provide medical review support ofmedical and promotional materialsfor the Medical, Legal, and Regulatoryreview committees Support Medical Information callcenter overflow and escalations, andaid in the development of customresponse letters Conduct quality reviews andmetrics for both US and GlobalMedical Information requestsOversight and engagement withexternal collaborators RCOCoordinate and participate in livetraining events at major conferencesor internal briefings Provide meaningful medical feedbackfor scientific materials in alignmentwith Medical Strategy of TESAROMedical Affairs E R OTAT I ONMedicalMedical InformationInformationMedical TrainingMedical TrainingPublicationsPublicationsMedical StrategyMedical DirectorELTECI V E R petitive IntelligenceCompetitive IntelligenceClinical DevelopmentClinical h Economics andHealth Economics andOutcomes ResearchOutcomes ResearchKunal Sunthankar, PharmD, MBAFirst Year Global Medical Affairs Fellow“The Medical Affairs Fellowship at TESARO is unique in that thefellow has tremendous opportunity to be involved in high level, fastpaced, exciting activities. This allows for a collaborative environmentbetween Medical Affairs core functions providing the fellow with astrong foundation in Medical Affairs Operations.”6PharmD Fellowship Program 2019 – 2021
Global Medical Affairs Fellowship TeamBerthold Greifenberg, MDSenior Vice President, Global Medical AffairsBerthold leads the Global Medical Affairs function at TESARO. Hehas had extensive experience throughout his career in various rolesranging from Medical Affairs, Clinical Development, and BusinessDevelopment which have transformed the oncology landscape atvarious pharmaceutical companies. Berthold has oversight of allMedical Affairs activities at TESARO and strives to align all dailyoperations to the TESARO medical strategy. Berthold received hismedical degree from the University of Kiel in Germany. He is excitedto be involved in the growth of the TESARO PharmD FellowshipProgram!Tom Giove, PhDSenior Director, Medical Affairs OperationsTom leads Global Medical Affairs Operations at TESARO, whichincludes the following key functions: Scientific Communications,Medical Information, and Medical Education and Training. Eachfunction is primarily focused on the advancement of medical andscientific communications between TESARO and the broaderhealthcare community. This requires a strong understanding ofemerging data from TESARO’s research, product information, andthe diseases we study. Each core function within Medical AffairsOperations achieves its mission through strong cross-functionalcollaboration, both internally and with our external healthcare providerpartners. Tom received his PhD from Boston University in Cell andMolecular Biology and remains committed to supporting importanteducational initiatives like the TESARO Fellowship Program.Noelle Wilson, PharmDDirector, Global Medical InformationNoelle leads the Medical Information team at TESARO andpioneered the fellowship program by serving as the MedicalInformation Fellowship Director. Noelle has extensive experiencewithin Medical Information at various pharmaceutical companies.Noelle received her PharmD from Northeastern University. She isexcited to see the growth of the TESARO Fellowship Program!PharmD Fellowship Program 2019 – 20217
om, and Karen Ann’s descriptionsGlobal Medical Affairs Fellowship Teamadd a period after each sentenceKaren Ann Cherkis, PhDDirector, Medical Education and TrainingKaren Ann joined TESARO as an Medical Science Liaison in Julyof 2015 and has served as the Director of Medical Education andTraining since June of 2017. In her current role, Karen Ann overseesboth the Medical Affairs Training and Grants and IndependentMedical Education Teams. She previously held roles in businessdevelopment for a contract research organization and medicalaffairs for an oncology-focused diagnostic company. Karen Annhas experience in translational research and clinical developmentof small molecules and biologics across multiple therapeutic areas.Karen Ann received her doctoral degree in genetics and molecularbiology from The University of North Carolina.be consistent and appear as: 3-h elective rotations may bem Overview to: The fellow will joinill be in Regulatory Strategy, withn other regulatory functions andChelsea Aiudi, PharmDManager, Medical InformationChelsea is a Medical Information Manager at TESARO. In herrole, Chelsea helps support the call center and field-based teamsthrough the creation of medical response letters and core datadecks. In addition, Chelsea collaborates cross-functionally throughher role on the Medical, Legal, and Regulatory review committeefor niraparib. Before joining TESARO in 2017, Chelsea worked inMedical Information at other oncology-focused pharmaceuticalcompanies in the Cambridge area. Chelsea earned her PharmD atthe University of Rhode Island.bottom of page 9 and addect to fill the space?8PharmD Fellowship Program 2019 – 2021
om, and Karen Ann’s descriptionsGlobal Regulatory Affairs (1 position)Program Overview: The Regulatory Affairs department drives rapid and efficientdevelopment of molecules and medicinal products, ensuring patient access totransformative therapies, while building a sustainable and resilient function within TESARO.The fellow will join the Regulatory Affairs team where the focus will be in RegulatoryStrategy with the opportunity to gain hands-on experience in otherregulatory functions and departments.add a period after each sentencePrimary Activitiesbe consistent and appear as: 3REOperationsh elective rotations may beAssist with the preparation of initialinvestigational new drug applications(US), initial clinical trial applications (exUS), annual reports and amendments. NAdvertising andPromotion/LabelingPromotionChemistry Manufacturingand Controls (CMC)ABLE3 - MONTHY R OTATIOSSupport the planning, development,review, and approval of regulatorydocuments for health authoritysubmission. GORATLUAILAVUnderstand the regulatory submissionprocess and assume responsibility forthe submission of documents. m Overview to: The fellow will joinill be in Regulatory Strategy, withn other regulatory functions andProvide regulatory guidance insupport of global clinical trials and thepreparation/submission of regulatorydocumentation. 3-month electiverotations may beavailable duringYear TwoParticipate in activities related to healthauthority interactions. bottom of page 9 and addect to fill the space?Apply learnings to communicateregulatory risks and updates, and toresolve action items at cross functionalmeetings. PharmD Fellowship Program 2019 – 20219
Global Regulatory Affairs Fellowship TeamChuck MillerVice President, Regulatory Affairs Strategy and LabelingChuck leads the Regulatory Strategy and Labeling function within GlobalRegulatory Affairs at TESARO. Regulatory Strategy and Labeling workswith multiple functions across the organization such as Clinical Research,Translational Research and Development, as well as with our externalcorporate partners to define and execute pathways for drug development,approval, and lifecycle management. Chuck began his career developingvaccines to prevent infection from arboviruses such as West Nile andDengue before moving into regulatory affairs. He has worked on drugapplications across multiple therapeutic areas at small and large companiesin the Cambridge/Boston area for over 20 years.Kevin Hollister, MS MBASenior Director, Regulatory Affairs Advertising and PromotionKevin leads the Global Advertising and Promotion function withinRegulatory Affairs at TESARO. This function entails working crossfunctionally with groups such as legal, medical affairs, marketingand corporate communications, in the creation and dissemination ofinformation about TESARO, the disease states we study, and the productsthat we develop and market. After graduating from the University ofCalifornia, San Diego, Kevin began his career as a molecular biologistat a research center in Southern California and then transitioned intoregulatory affairs. Since then he has worked in various regulatory affairsfunctions for several pharmaceutical/biotech companies.Irene Darras, PharmDManager, Regulatory Affairs StrategyIrene is a Regulatory Affairs Strategy Manager for the immuno-oncologyportfolio at TESARO. In her current role, Irene supports the planningand execution of the global regulatory strategy, and provides regulatoryguidance for studies in patients with advanced solid tumors. Prior to joiningTESARO, Irene completed a two-year post-doctoral fellowship in GlobalRegulatory Affairs at Bayer HealthCare. At Bayer, she led the developmentand submission of regulatory documents for key oncology assets. Irenereceived a PharmD degree from MCPHS University in Boston, MA.Kate Ho, PharmDManager, Regulatory Affairs Advertising and PromotionKate is a Regulatory Affairs, Advertising and Promotion Manager. In herrole, Kate helps to create and disseminate meaningful product informationthat is truthful and accurate as well as furthers the mission of thecompany. Kate previously completed a two-year post-doctoral fellowshipin Regulatory Sciences, Advertising and Promotion at Biogen, where shegained experience working on advertising, promotion and labeling, froma regulatory perspective, and also worked in both medical and marketingroles. Kate earned her PharmD degree from Purdue University.10PharmD Fellowship Program 2019 – 2021
PARTNER RTHtonarea.rn Universit y has developedton area.C H A L L E N G EA C C E P T E DNortheastern Universityis a global, experiential, research university built ona tradition of engagement with theingworld,newpartnershipscreatecreating a rn,weCencourageour TstudentsC HAtoLL ENG AtEA CE PE Dandlearnfromeachother, izenswhorealizetheirknowledgeandactionshaveing new par tnerships createulinamultitudeya far-reachingimpact.Students ignite theirpassion for learning andareofexposed to industrthe endlesspossibilitiesandlearnfromeachother,taround themthroughtransformative experiential education.ul inamultitudeof industr yostonTHE NORTHEASTERN FELLOWSHIP DIFFERENCEostonThe Northeastern University Fellowship Programa dynamicacademicenvironment offeringfellowsrn ty opportunitiesis intheheartaoexperiences. Fellows are also provided with severalto engagewith students utilizinga layered rning model, from co-precepting studentsofwithin Northeastern’sunique co-op program to the incorporation whthpioneersinnovation, Massachusett s General es.tonarea is ameltingpot ofcthpioneersofinnovationwhtonareais a melting pot of cWHATYOU WILL EXPERIENCE 12 14Apply teaching and learning seminar skills to facilitate small and large group classroom teaching with faculty mentorsCo-precept students on co-op education and advanced pharmacy practice experiencesCreate and publish scholarly research and review articles with a faculty advisorPresent research at scientific and clinical meetingsCollaborate with fellows & residents in Boston during professional development/teaching seminarsEngage with faculty who participate in various interdisciplinary graduate programs including biotechnology,nanomedicine, immunology, health informatics, and drug discoveryNUfellowship.comReturn to TOC11
PARTNERCURRENT PARTNERS OF THE NORTHEASTERNS OFUNIVERSITYTHEFELLOWSHIP PROGRAMNORTHrnUniversitNortheastern University has icaldevelopedcompanieswithin thePARTNEROFTHENORTHtongreaterarea.Bostonarea.rn Universit y has developedton area.CHACL L E N G EHA C C E PATEDLLENGEACCEPTEDingThesenewexciting new partnershipsparcreate a largetnershipsnetwork of postdoctoral fellows.Fellows have opportunitiescreatetoC H A L L E N G EA C C E P T E ioningotherthemto, ting new par tnerships createulinbe successfulain a multitudemultitudeof industryfromsettings.of industryandlearneachother,tul in a multitude of industr yostonLife in Bostonostonrn UniversitNortheastern University is in the heart of Boston,ystepsisaway frominthe famoustheFenway Park andheardowntowntoareBoston.surroundedWe are surrounded by top tier academicresearch Hosisare surrounded by top tier athpioneersteeming with pioneers of innovation who areofcommittedinnovationtointellectualcuriosity and scientific advancement. Thewh, Massachusetts GeneralHostongreaterareaBoston area is a meltingispot of culture,aofferingmeltingworld-classattractions and rich history.pot ofcthpioneersofinnovationwhton area is a melting pot of c1213Return to TOCNUfellowship.com15
Application ProcessLaunch your post-graduate career. Apply now!Fellows will be selected on a nationally competitive basis. All candidates must have aDoctor of Pharmacy degree from an ACPE-accredited college of pharmacy by June30th, 2019. Candidates who wish to apply must submit their formal application toNortheastern University’s job website by December 1st, 2018.APPLICATION TIMELINE AND STEPS:PharmD Fellowship – Application ProcessSeptemberOctoberNovemberDecemberJanuary1. ApplicationRolling ApplicationApplication Deadline12/012. Phone Interviews3. ASHP Midyear12/02 - 12/044. Onsite InterviewsPost-MidyearStep 1: APPLICATIONStep 2: PHONE INTERVIEWSStep 3: ASHP MIDYEARStep 4: ONSITE INTERVIEWS Complete application byDecember 1, 2018 11:59 PM PT Applications are reviewed on arolling basis - apply early! Eligible candidates may beoffered phone interviews on anad-hoc basis upon completionof NU application prior to ASHPMidyear Eligible candidates are offeredinterviews at ASHP Midyear Midyear reception attendanceupon invitation Onsite interviews are offeredupon successful completion ofSteps 1-3 Fellowship offers extended tocandidates Required materials*:- Curriculum Vitae (CV)- Official/Unofficial collegetranscript- Letter of Intent- Contact info of 3 references*Letters of Recommendation are not required until formally requestedApply Now: NUfellowship.comQUESTIONS?For answers to frequently asked questions and for other information Visit: NUfellowship.comEmail: Pharmdfellowship@tesarobio.comAddress your letter of intent and three letters of recommendation to:Debra Copeland, BS, PharmD, RPhDirector, Office of Experiential EducationAssociate Clinical ProfessorNortheastern University Bouve College of Health SciencesDepartment of Pharmacy & Health System Sciences360 Huntington Ave, R218TFBoston, MA 02115D.Copeland@northeastern.eduPharmD Fellowship Program 2019 – 202113
the Regulatory Affairs team where the focus will be in Regulatory Strategy, with the opportunity to gain hands-on experience in other regulatory functions and departments. v. Would like to remove the TESARO logo on the bottom of page 9 and add something similar to this gradient of jewels effect to fill the space? vi.
