leo pharma

LEO PHARMA

A pioneer in medical dermatology.

Fellowship Program

A MESSAGE FROM LEADERSHIP…………………………………………….. 3

ABOUT LEO PHARMA…………………………………………………………………. 4

FELLOWSHIP PROGRAM LEADERSHIP TEAM….…………………. 7

MEDICAL AFFAIRS FELLOWSHIP……………………………………………. 9

REGULATORY AFFAIRS FELLOWSHIP…………………………………… 12

WHILE AT LEO PHARMA INC.…………………………………………… 15

FELLOWSHIP ALUMNI…….…………………………………………………………. 17

T A B L E O F C O N T E N T S

2(C) 2021 LEO Pharma Inc. All Rights Reserved.

Dear Rutgers Pharmaceutical Industry Fellow Candidates,

On behalf of LEO Pharma Inc., we would like to thank you for your interest in the Post-Doctoral Pharmaceutical Industry Fellowship Program. The pharmaceutical industry provides many exciting and dynamic opportunities, and the same is true at LEO Pharma more than ever before.

We are a research-based pharmaceutical company founded and headquartered in Denmark in 1908. Our global organization helps improve people’s lives with innovative treatments for psoriasis, atopic dermatitis, and rosacea. Additionally, we are addressing the huge unmet medical need for people living with skin diseases

This brings energy, but we need talented people such as yourself to sustain it. People who believe in and model our values of customer focus, integrity, adaptability, innovation, and passion . We are a company with a strong heritage and an even stronger future. Come pioneer with us.

We see the strategic importance of a partnership with Rutgers through the RPIF Program. With 66% growth in the past 2 years in our Medical Strategy & Scientific Affairs and Regulatory Departments, it is critical for us to attract and develop the next level of scientific leaders. We aspire to offer a dynamic and rewarding opportunity for fellows to begin their career with LEO Pharma.

Best regards,Christopher Posner

President and CEO, LEO Pharma Inc.

A M E S S A G E F R O M L E A D E R S H I P

www.leo-pharma.us

(C) 2021 LEO Pharma Inc. All Rights Reserved.

EUR 1,359 million in 2020 revenue

960 scientists and specialists in R&D

21% of revenuereinvested in R&D

Products sold in 130+ countries, helping 93 million patients in 2020

6,000 employees in60 countries

Founded in Denmark in 1908

Click to learn more: LEO Pharma US | LEO Pharma | LEO Pipeline | LEO Products | LEO History

Our ambition is to be a global leader in medical dermatology

2030 Strategic Goals

Deliver double-digit growth Launch an innovative product every 2-3 years

Pioneer first-in-class and best-in-class therapies Build a leading portfolio Rank as a top-five company

within medical dermatology

About LEO Pharma


https://www.leo-pharma.us/Home/Who-We-Are/Our-History.aspx

https://www.leo-pharma.com/

https://www.leo-pharma.us/Files/Billeder/Q12021_externalpipeline%20_Final_6121.pdf

https://www.leo-pharma.us/Home/Our-Products.aspx

https://www.leo-pharma.us/Home/Who-We-Are/Our-History.aspx

INTEGRITYWe are a responsible company and keep our promises. We act and communicate in an open, honest and trustworthy way.

CUSTOMER FOCUSWe improve the quality of life of people through competitive products and services. To truly understand our customers, we engage in partnerships and dialogue.

INNOVATIONWe all have a responsibility to innovate and challenge the status quo. We share and implement our ideas and learn from our failures.

ADAPTABILITYWe stay agile in a dynamic world by seeking solutions that are flexible, scalable and cost effective. We seize new opportunities as they arise.

PASSIONWe will be the best. We care about people and take pride in what we do. We strive to support and inspire others in our efforts to make a difference.

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O U R V I S I O N

We are the preferred dermatology care partner improving peoples lives around the world

O U R V A L U E S

LEO Pharma is dedicated to helping people achieve healthyskin by developing life-changing medicines


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U N I T E D S T A T E S & C A N A D A A S I AE U R O P E

L E O P H A R M A A L L I A N C E S

LEO SCIENCE AND TECH HUBPartnerships to identify, develop and fund innovative technological solutions

LEO PHARMA OPEN INNOVATIONOpen access for compound testing at LEO Pharma’s laboratories

LEO Pharma Globally


P R E C E P T O R S A N D E X E C U T I V E C O N T A C T S


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L E O P H A R M A F E L L O W S H I P L E A D E R S H I P T E A M

Cross-Functional Preceptors

John ZoidisAssociate Director

Publications

Olga OstrovskayaMedical Director,

Early Portfolio & Topicals

Kristi DoverSenior Director

National MSL Team

Antonella Lozito-Heerschap

VP, Global Regulatory Strategy

Adriana GuanaVP, Med. Strategy &

Scientific Affairs

Executive Sponsors

Nikeshia Dunkelly-AllenSr. Mgr. Med. Strategy &

Scientific Affairs

Janine JazayeriAssoc. Dir. Global Reg.

Labeling Strategy

Fellowship Preceptors

Patricia PalmerSr. Director, HRBP

Ryan GoodrichAssoc. Director

Learning & Development

People & Communications


Shan AliManager,

Scientific Affairs

Lois JessenSenior DirectorUS Regulatory

Advertising & Promotion

Ellen BortnikerDirector, Medical Info

& Communications

Jen WillettsSr. Director

Medical Outcomes Liason

Shannon SchneiderMedical DirectorTralo Scientific

Affairs

M E D I C A L S T R A T E G Y & S C I E N T I F I C A F F A I R S F E L L O W S H I P

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L E N G T H : 2 Y E A R SL O C A T I O N : M A D I S O N , N J


Medical Strategy and Scientific Affairs Fellowship

The Medical Affairs Fellowship will be a two-year program designed to expose the Fellow to the core functional areas of the U.S. Medical Affairs Department (Medical Information , Publications, Medical Strategy for established and innovative portfolios, Field Medical Science Liaison Team, and the Field Medical Outcomes Liaison Team ) with a focus on the innovative portfolio.

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OVERVIEW

2 Year Rotational Medical Affairs Experience

4 months Medical Information • Provide efficient and unbiased medical information on LEO products to healthcare

professionals, consumers, and employees• Conducts research, plans, and authors Standard Response Letters (SRL), FAQs,

and customized responses to unsolicited information requests• Interacts directly with HCPs and consumers to respond to unsolicited requests for

Medical Information or escalated inquiries.

2 months Publications • Participate in developing and driving the execution of internal and external

scientific communication strategy • Participate in scientific congress activities, including development of congress

materials and posters

2 months HQ Medical Strategy Early Portfolio and Topicals • Collaborate with Medical Director and team, to develop, maintain and monitor

execution of medical tactical plans for the Topical franchise


PRECEPTORS

Nikeshia Dunkelly-Allen, PharmDSr. Manager Medical Strategy & Scientific Affairs

&Shan Ali, Pharm DManager, Scientific Affairs

Medical Strategy and Scientific Affairs Fellowship (Continued)

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2 Year Rotational Medical Affairs Experience

8 months HQ Medical Strategy Tralokinumab • Collaborate with cross-functional teams including; Marketing, Commercial, Communications, Regulatory Affairs, Legal, Market Access, and Clinical

Research as it relates to Medical Affairs’ activities• Assist in the development of medical content for congresses, symposia, and advisory board meetings with top-tier Key Opinion Leaders (KOLs)• Contribute to projects that directly impact brand development and life cycle management

4 months Medical Science Liaison• Engage thought leaders in scientific discussion during field-based activities with Medical Science Liaisons (MSLs) • Facilitate discussion and identification of insights from the field and various matrix teams to determine unmet medical needs and competitive

intelligence insights and inform medical strategy• Develop relationships with HCPs (academic and non-academic physicians, nurse practitioners, and physician assistants) to ensure that there is access

to current medical and scientific information.

4 months Medical Outcomes Liaison Managed Care • Proactively and reactively engage payer/PBM executives and their designates (from pharmacy, medical, quality, value assessment, etc.), external

scientific experts, and relevant business influencers in clinical and health outcome-based information for all portfolio and pipeline products to inform access and reimbursement decisions


G L O B A L R E G U L A T O R Y A F F A I R S

L A B E L I N G S T R A T E G Y A N D U S A D V E R T I S I N G A N D P R O M O T I O N F E L L O W

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L E N G T H : 2 Y E A R SL O C A T I O N : M A D I S O N , N J


Labeling Strategy and US Advertising & Promotion Fellowship

The product information (label) is the conclusion of the entire clinical development. It serves the needs of patients, health authorities, health care professionals and payers.

The Regulatory Affairs Fellowship will be a two-year program designed to expose the Fellow to the core areas of regulatory labeling. As the label is the foundation for promotional materials, the Fellow will be offered a period with our US advertising and promotion team that ensures that FDA regulations for promotional materials are applied for our products.

LEO Pharma’s Labeling Strategy team has a high focus on a learning culture, and we are dedicated to being strong strategic partners throughout the life cycle of our products. Throughout the program, the Fellow will build strong collaborative partnerships with a variety of key stakeholders across LEO Pharma (Marketing, Medical Affairs, Market Access, Safety, Medical, and many others).

Short-term rotation and shadowing opportunities within Regulatory Affairs and other departments at LEO Pharma can be provided based on interest and business need.

OVERVIEW


PRECEPTORS

Janine Jazayeri, PharmD, RACAssociate Director, Global Regulatory Labeling Strategy

&Lois Jessen, MS, PharmDSenior DirectorUS Regulatory Advertising & Promotion

Labeling Strategy and US Advertising & Promotion Fellowship

FELLOWSHIP ACTIVITIES AND RESPONSIBILITIES MAY INCLUDE, BUT ARE NOT LIMITED TO:

• Gain experience driving the global labeling strategy for one or several products, ensuring alignment with the global regulatory and commercial strategies.

• Gain specialized knowledge regarding labeling requirements globally, including management of the Company Core Data Sheet (CCDS) and strategies in key markets, including details of the United States Prescribing Information (USPI) and the European Summary of Product Characteristics (EU SmPC).

• Contribute to the optimal target product label, target product profile, and target product claims for products in development.

• Analyze the evolving regulatory landscape for impact on our products in support of regulatory decision making.

• Provide strategic and scientific input to the design of the clinical development program to support the label.

• Participate in labeling negotiations with health authorities.

• Provide strategic guidance on FDA regulations applying to advertising and promotion of branded and disease-awareness materials.

• Analyze the impact of FDA Office of Prescription Drug Promotion (OPDP) enforcement actions, assess the regulatory implication to commercial activities and communicate new regulatory standards to the organization.

• Collaborate directly with marketing teams from concept through review and approval, up to and including OPDP submissions.

• Liaise with product leads and labeling teams to assess interdependency of labeling and US promotion.

• Support global teams on initiatives developed for US audiences.

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Global Regulatory Labeling Strategy US Advertising & Promotion


L E T ’ S P I O N E E R

T R A I L B L A Z I N G A N E W P A T H F O R P H A R M D F E L L O W S A T L E O P H A R M A


C U L T U R E , D I V E R S I T Y , A N D E M P L O Y E R A C H I E V E M E N T

“AGILE” and employee-led team responsible for acting as the voice of the organization in providing opportunities for colleagues to share ideas, implement projects, increase engagement and establish a networked culture within LEO Pharma.

Available Programs• Thayer Leadership Speaker Series• LEO Talks• Round-Table Sessions• Leadership related blogs and media• The ONE LEO Podcast• eMentor Connect• The Team Dynamics Toolkit• Crowd-Sourced Culture Innovations• Volunteering Opportunities• Events & Celebrations

Our Mission• Strengthen diversity, equity and inclusion

throughout LEO Pharma Inc. by leveraging – and celebrating – our diverse voices, backgrounds, and experiences.

• Foster a workplace where employees feel valued and free to be their authentic selves, and feel supported with resources, including training and development opportunities.

• Champion strategic and tactical insights on key business and HR initiatives and seek diverse perspectives to drive innovation.

• Make a positive and tangible impact on our communities.


Top WorkplaceNJ.com, 2020

Top WorkplaceNJ.com, 2019

LTEN Excellence AwardInnovative Practitioner, 2019

PM360 Elite AwardDigital Crusader, 2018

Specialty Pharma/Biotech Company of the YearPM360 Trailblazer, 2018

R U T G E R S F E L L O W S H I P A L U M N I A T L E O P H A R M A I N C .

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REGULATORY AFFAIRS

Antonella Lozito-Heerschap Head of Global Regulatory Strategy

Paulina Estrada Director, Global Regulatory Strategy

Vickie Laurent Global Regulatory Lead, Global Regulatory Strategy

Lisa Pruss Global Regulatory Lead, Global Regulatory Strategy

Encarnacion Suarez Senior Director, Global Regulatory Strategy

MEDICAL AFFAIRS

Nikeshia Dunkelly-Allen Senior Manager, Medical Affairs

Linda Chiou Senior Medical Information Senior Manager

HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR)

Miraj Patel Director, HEOR

My fellowship in US Medical Affairs, at Pfizer was an opportunity for me to gain hands-on experience in a pharmaceutical company during a relatively short time. During the fellowship I worked on several impactful projects that allowed me to gain a better understanding of how medical affairs supports the overall organization. The fellowship was a major steppingstone to where I am now and provided an excellent foundation for my current success.

- Nikeshia Dunkelly, PharmD, Sr. Manager, Medical Strategy and Scientific Affairs


I owe my entire professional career to the fellowship and to the place in life where it brought me. Not only would I not have been able to bring 3 new drugs to market, but I would not have met my husband and started our family!

- Antonella Lozito-Heerschap, PharmD, Head of Global Regulatory Strategy

Rutgers Pharmaceutical Industry Fellowship ProgramErnest Mario School of Pharmacy Rutgers, The State University of New Jersey

Carolyn Seyss, Pharm.D. Fellowship Director Institute for Pharmaceutical Industry FellowshipsErnest Mario School of PharmacyRPIF Alumna

Michael Toscani, Pharm.D.Research Professor, Fellowship Director Emeritus Institute for Pharmaceutical Industry FellowshipsErnest Mario School of Pharmacy

Joseph A. Barone, Pharm.D., F.C.C.P.Dean and Professor IIErnest Mario School of PharmacyRutgers University

Program History

In 1984, at Rutgers, The State University of New Jersey, the Ernest Mario School of Pharmacy and two pharmaceutical companies began a collaborative pilot program to evaluate the potential contributions of clinically-trained pharmacists within a pharmaceutical industry practice setting. Following the successful pilot, the Rutgers Pharmaceutical Industry Fellowship (RPIF) Program grew significantly and expanded to include 21 companies within the pharmaceutical and biopharmaceutical industry and approximately 300 Fellows.

In 2002, Dr. Ernest Mario generously provided an endowment to establish the Institute for Pharmaceutical Industry Fellowships to enhance and promote the role of pharmacists in industry through the RPIF Program. The Institute staff members:• provide leadership and administrative support;• promote quality, communication, and scholarly activity; and• arrange specialized fellowship training opportunities within the pharmaceutical

and biopharmaceutical industry.

In 2018, our Program expanded to offer interdisciplinary Fellows’ training by adding select physician fellowship opportunities to our well-established program.

The RPIF Program has thrived under the leadership of the founder, Dr. Joseph A. Barone, Dean and Professor II of the Ernest Mario School of Pharmacy, Dr. Carolyn Seyss, the Director for the Institute for Pharmaceutical Industry Fellowships, and Dr. Michael Toscani as Director Emeritus.

More than 1,300 Post-Doctoral Fellows have completed the RPIF Program, most of whom are experiencing influential and rewarding careers in the pharmaceutical and biopharmaceutical industry throughout the US and abroad. The RPIF Program has Preceptors and Mentors from industry who share their knowledge and experiences with the Fellows through an intense but closely-guided training program. Assignments and projects are challenging, meaningful, and designed to enhance understanding of the pharmaceutical and biopharmaceutical industry and the Fellow’s functional area(s). Our goal is to provide the environment for Fellows to build the foundations for their careers as future leaders in the industry.

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.

https://pharmacy.rutgers.edu/

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Key Program FeaturesThe Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growth and development offuture pharmaceutical and biopharmaceutical industry professionals and leaders through the followingkey program features:

Family of Leading Companies – Partners include several of the top global pharmaceutical and biopharmaceutical companies.

Outstanding Alumni Track Record – Over 1,300 alumni hold prominent positions at many leading companies.

Strong Network — Fellows develop valuable, lasting connections with each other, alumni, Preceptors, and faculty.

Trusted and Proven Since 1984 — the Rutgers Fellowship Program is nationally recognized, trusted, and proven as the key pathway to industry for pharmacists as future leaders.Enhanced Career Development – Breadth of experiences informs career path choices and increasingly challenging assignments build depth of experience, enhancing the potential for accelerated career paths.Rigorous Academic Component – Rutgers affiliation provides academic and professional development opportunities.

Rutgers, The State University of New Jersey, with over 71,000 students in its three campuses, is one of the major state university systems in the United States. The New Jersey College of Pharmacy was founded in 1892 and was incorporated into the University in 1927. The Ernest Mario School of 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 Doctor of Pharmacy degree program. The Rutgers Ernest Mario School of Pharmacy is located on the University’s main science and technology campus in Piscataway, New Jersey. Because of its relationship with and, for most, close proximity to the nation's leading pharmaceutical and biopharmaceutical companies, the Ernest Mario School of Pharmacy and the RPIF Program are uniquely capable of providing fellows with advanced training in the pharmaceutical and biopharmaceutical industry.

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:pharmafellows.rutgers.edu

All application materials must be submitted electronically to the RPIF Website.

Required Items Deadline*Letter of Intent (LOI) November 1st

Curriculum Vitae (CV) November 1st

3 Letters of Recommendation (LORs) December 5th

Your Letter of Intent & 3 Letters of Recommendation should be addressed to:

Joseph A. Barone, Pharm.D., F.C.C.P.Dean and Professor IIErnest Mario School of PharmacyRutgers, The State University of New Jersey160 Frelinghuysen RoadPiscataway, NJ 08854-8020

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.

*Candidates are considered on a rolling basis. Submission of materials prior to deadline is strongly encouraged.

https://pharmafellows.rutgers.edu/

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