1. Created byInformation Design Nursing Leadership Roles in the Pharmaceutical Industry S. Newton, RN, MS, AOCN®, AOCNS, C. Pence, RN, MSN, OCN, L. Sundquist, MSN, AOCN®, MBA, M. Smith, RN, MSN/ED OCN, L. Friedman RN, BSN, MPA, J. Di Brango, RN, BS, M.Ed, M. Avello, RN, BSN, OCN Overview The increasing complexity of the drug development process as well as the advanced sophistication of newly approved oncology agents has created a heightened need for nurses to assume leadership roles both during the drug development process and in the education of clinical professionals. In an effort to better understand the nursing leadership opportunities within the pharmaceutical industry the ONS PIN SIG (Pharmaceutical Industry Nurses Special Interest Group) has examined various pharmaceutical career paths. Methods ONS Pharmaceutical Industry Nurses Special Interest Group (PIN SIG) members were asked to describe their profession, offer advice on entering into their profession, and compare and contrast their current role to that of a more traditional nursing role they may have held in the past. Best practices for entering into the field Build strong clinical, administrative and organizational skills. Gain experience in a clinical trial role with an emphasis on conducting and providing oversight of clinical trials. Gain experience through internships or temporary contract positions C. Christine Pence, the Clinical Scientist experience; “The transition from clinical care to industry can be a challenge, however maintaining a focus as a patient advocate first and foremost, maintains my close identity with Nursing, a role which is close to my heart. As a Clinical Scientist, I have the opportunity to touch millions of patients with the clinical trials and approved agents I support. Although the faces and names of these patients and families go unknown, I know they are there, and it is their hopes and dreams which drive me to excel each and every day.” A. Role & Responsibility Provides centralized marketing expertise to internal development team. Coordinates market planning while maintaining a keen sense of patient needs by interacting with patients and related advocacy groups. B. Entering into the field Entry level credentials: BS required, MBA, or equiv. preferred Entry level skill set  4 yrs marketing experience and 2 years of relevant pharmaceutical marketing experience. Experience in direct-to-consumer (DTC)/ direct-to- patient (DTP) marketing. Additional Background and Field of Interest Experience in oncology nursing or a related health care field Direct experience in the patient care setting or patient advocacy roles Best practices for entering into the field Leverage your oncology nursing experience Gain experience in marketing of pharmaceuticals or advocacy needs C. Lisa Sundquist, the Marketing Manager experience; “My transition to the pharmaceutical industry has allowed me to contribute to the most important customer, the patient, as well as, continue to utilize my skills as a nurse, educator, and advocate while learning new skills to enhance my overall effectiveness. I maintain my connection with patients through continuing to provide support and encouragement to those recently diagnosed with cancer and/or their support system through one-on- one conversations and presentations. A. Role & Responsibility Develop the clinical content of programs and materials for community-based oncology practices. Liaison with pharmaceutical industry partners to bring clinical trials to our customers. Act as Principal Investigator on outcomes studies investigating the utility of various clinical resources B. Entering into the field Entry level skill set Clinical expertise, advanced writing, and communication skills Understanding of regulatory and business requirements related to the conduct of clinical trials Experience interfacing with stakeholders in the pharmaceutical industry Best practices for entering into the field Strengthen clinical, teaching, administrative and organizational skills Gain experience in conducting and providing oversight of clinical trials. C. Lyssa Friedman, the Clinical Trials Network Director experience; “I prefer this rapidly changing industry over the more conservatively paced healthcare delivery environment. I am intellectually stimulated by my exposure to cutting-edge oncology, technological developments and innovative projects, with the overall goal to advance patient care. The periodic travel and business meetings fit my personality style. Disadvantages include some long hours and unpredictable scheduling and the inability to interact directly with patients.” A. Role & Responsibility Team Leader in delivering product and medical information to patients and health care professionals. Liaise with oncology colleagues to operationalize customer focused programs C. Martine Avello, the Area Business Manager experience: “The positives of this position include flexibility, a unique working environment, and the ability for increased learning and participation in nursing groups, such as ONS. Travel to different locations you may not otherwise have the opportunity to visit is also a positive aspect.” A. Role & Responsibility Assist with oncology sales, providing ongoing product and clinical support to both external and internal customers Assisting customers with safe handling compliance by ensuring adherence to recommended best practices. B. Entering into the field Entry level credentials Licensed Registered Nurse, Bachelor’s degree, Nursing (preferred) Entry level skill set  5 years experience in oncology nursing (OCN preferred)  1 experience as a Clinical Support Manager Strengthen understanding of oncology and the use of hazardous drugs across the health care setting C. Maggie Smith, the Clinical Support Specialist experience “The work environment is fast paced with a high level of autonomy which enhances your organization and communication skills. When compared to the traditional nursing role, there are some cons to this position such as travel which ranks number one on my list” A. Medical Science Liaison (MSL) MSLs are field-based professionals employed by most pharmaceuticals, who engage in scientific exchange and education of pharmaceutical products with known thought leaders and community-based clinicians. Most MSL positions include a component of clinical research through assisting in the design and structure of company-sponsored trials and facilitating grants for independent investigator research. Many companies require a doctoral level degree such as an MD, PhD, or PharmD in order to work in this role. B. Entering into the field Entry level credentials: Lisc. RN or Pharmacist Entry level skill set  2 yrs clinical experience, adult oncology preferred Best practices for getting into the field Strengthen knowledge in disease management Gain experience as a Study Coordinator Additional Background and Field of Interest A desire to help cancer patients navigate the health care system. A keen interest in working with leading patient advocacy groups C. John Di Brango, the Brand Leader Experience: “As an oncology nurse within the pharmaceutical industry we are used as consultants to brand teams, Public Affairs, Clinical Development, and participate in many of the advocacy groups’ projects. The nurse in the pharmaceutical company is a valued resource and Registered Nurses hold many leadership positions. Some of the pros include an ability to maintain a work/life balance, the professional environment, access to research and cutting/leading edge oncology information, and assisting cancer patients navigate the health care system. A negative is the loss of contact with direct patient care.” A. Role & Responsibility Manages regionally based oncology account specialists Accountable for sales trends within the region. Responsible for the development of the sales representatives, strategic planning and execution to meet sales objectives, continued education, and administrative duties. B. Entering into the field Entry level credentials: min. BS, MBA or equiv. preferred Entry level skill set A successful record of sales experience, management experience, and clinical expertise Best practices for getting into the field Strengthen organizational and planning skills Mentor with other senior sales representatives in the area, seeking insight and information on accounts beyond your expertise Address selling as an opportunity to educate others on your product, with a key focus on the needs of the patient. Objectives The primary objective of this synopsis is to facilitate non-industry nurses in identifying; l Non-traditional leadership nursing opportunities l Compare and contrast various nursing leadership roles in the pharmaceutical industry l Understand contributions of nursing leaders in the development of pharmaceuticals Results A. Role & Responsibility Provide clinical expertise to a global development team. Author clinical protocols, study reports and key regulatory documents Collaborate with both internal and external stakeholders in the creation of research and development plans for investigational products. B. Entering into the field Entry level credentials; MSN or equiv. Entry level skill set Clinical expertise in the care and treatment of the oncology patient Advanced writing and problem solving skills Excellent customer service and communication skills Understanding of regulatory and business requirements related to the conduct of clinical trials B. Clinical Research Associate (CRA) Responsible for management of study data at the site level. Key contact between the sponsor and the investigational site to ensure the accuracy and completeness of study data Performs site initiations followed by periodic follow up visits, ensuring regulatory requirements at the site level are closely followed. C. Medical Information Specialist Works within pharmaceutical call centers, addressing questions/concerns from clinicians and patients in regards to company products. Researches medical information to provide a quick, accurate and thorough response to caller requests. Communicates important product and/or medical information to relevant internal functions as necessary in support of product changes, safety issues and other sentinel events. Supports product booths at professional scientific meetings. D. Medical Education Program (MEP) Manager Facilitates pharmaceutical support to medical education companies for continuing education programs, such as symposiums, print monographs, CD-ROMs, or audio programs. Responsibilities include the evaluation of proposals submitted by the medical education company, the processing of the grant requests, and attending and evaluating the event or the finished product. Although the pharmaceutical sponsor cannot directly influence or suggest content of the programs, the MEP may be requested to review content for scientific accuracy. Summary There are a plethora of roles for nurses within the pharmaceutical industry. The intent of this poster was to describe many of these general roles, which may fall under various titles across the industry, and offer a guide to nurses who have an interest in entering these leadership roles. It is vital that the nursing community continues to challenge common boundaries and explore non- traditional opportunities where the impact of nursing can further serve the greater good of patient care. This descriptive analysis was limited to members of the PIN SIG. Future assessments should reach beyond these members in an attempt to capture the impact of pharmaceutical nurses across a larger community and define the unique differences these nurses have made to patients indirectly through their roles within industry. Clinical Development Scientist Patient Marketing Manager Clinical Trials Network Director Oncology Brand Leader Area Business Manager Additional Leadership Roles ONS Pharmaceutical Industry Nurses Special Interest Group (PIN SIG) Clinical Support Specialist