Celltrion USA
About the Company:
Celltrion US A is Celltrions U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrions unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.
Celltrion Healthcar e, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.
Celltrion Healthca re provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
POSITION SUMMARY Reporting to the VP of Clinical Development, the Evidence Generation Head (Medical Epidemiology & Real-World Effectiveness) will support the medical team needs through gaining epidemiology & real-world effectiveness for a given brand/s and will be responsible for medical activities for differentiation through relating to real world utilization and effectiveness data.
He / She will be responsible for leading, coordinating, overseeing, and providing guidance to the medical teams and other cross-functional team members throughout the organization to guarantee seamless and timely execution of the epidemiology, real-world database studies to support the medical integrated evidence generation strategy.
This person will also participate in the Scientific Review Committee (SRC), Lifecycle Management sub team of the Medical Leadership Team (MLT) and contribute to the parts of Integrated Evidence Generation Plan (IEGP) for product/s they are responsible for.
KEY ROLES AND RESPONSIBILITIES Provide leadership to real world evidence generation to support life-cycle management strategy, identify needs for high value RWE and database studies, and oversee their development, management, and execution. Ensure alignment across clinical trials and HEOR studies. Provide input into novel real world evidence generation opportunities for [the product/s] including identifying novel sources of data and novel approaches to leveraging databases and survey data to support the therapeutic area strategy and improve the understanding of real-world effectiveness of the product . Lead the development of RWE generation including chart reviews aligned with LCM strategic imperatives Develop medical strategies to obtain relevant data evidence from Real World Evidence, consistent with strategic objectives for each product. Ensure that appropriate processes are in place for review, approval, management and support of studies. Provide input to evaluation of investigator sponsored studies and external study collaborations related to real world evidence and database reviews Communicate regularly and timely the product RWE strategy to US Medical & Clinical colleagues and cross-functional team members. Ensure that RWE studies planned fit into the overarching organizational strategy Ensure and oversee the planning, execution and reporting of RWE studies and chart reviews in accordance with established budgets and timelines Monitor performance of RWE activities (e.g. value creation) from conception through publication of database study results and take corrective actions or escalate issues as appropriate. Contribute to continuous improvement of RWE study related processes and best practices. Establish a strong network within the Medical Affairs organization and with other stakeholders namely Marketing, Market Access, HQ R&D, Global Medical Affairs, Clinical Planning, Regulatory, and Pharmacovigilance teams. Partnering with and providing input to Launch/Commercial Team(s) to define RWE strategy to impact the achievement of objectives and maximize the value of each Zymfentra in the franchise. Representing Global Medical Affairs team at medical meetings, advisory boards, outreach meetings at key institutions and/or patient associations, and in interactions with KOLs related to real world evidence generation. Ensure a patient-centric approach to the development of medical strategies for product development as well as possible services which can enhance the value proposition of the product; provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials
WORK EXPERIENCE Advanced degree (e.g. PharmD PhD or M.D.) combined with research background is required along with industry experience working in related areas (e.g. LCM, Clinical Development, HEOR, Epidemiology & RWE, etc.),
preferably related to [Gastroenterology and IBD ]. An MPH is desired but not required. A minimum of 5-7 years experience conducting studies in a pharmaceutical or equivalent environment is strongly desired. Firm working knowledge of GCP, scientific methodology, protocol design, epidemiology, biostatistics, outcomes research, regulatory requirements and compliance for conduct of clinical research are strongly desired.
QUALIFICATIONS Regional or Global experience is highly advantageous. Experience working within an international company with a complex organizational environment; able to operate in a matrix team-oriented structure. Strong understanding of the pharmaceutical/biotech drug development and commercialization process. Able to work on projects in coordination with cross-functional and, where applicable, Alliance partners, and establish excellent working relationships and credibility. Excellent communication and presentation skills with the ability to present scientific data in a credible manner. Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena. Leadership skills: personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances. Collaborative and proactive approach, with a hands-on, roll-up-the-sleeved style and attitude, and sense of urgency is essential Highest integrity; committed to ethics and scientific standards.
EDUCATION Advanced degree in a health science related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry.
CORE COMPETENCIES Knowledge
Oncology, biologics, biosimilars, medical terminology and regulatory requirements. Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Companys products. Collaboration - ability to communicate across functions and at all levels in the organization. Compliance
understands industry regulations to maintain compliance.
Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#LI-DD
Celltrion US A is Celltrions U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrions unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.
Celltrion Healthcar e, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.
Celltrion Healthca re provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
POSITION SUMMARY Reporting to the VP of Clinical Development, the Evidence Generation Head (Medical Epidemiology & Real-World Effectiveness) will support the medical team needs through gaining epidemiology & real-world effectiveness for a given brand/s and will be responsible for medical activities for differentiation through relating to real world utilization and effectiveness data.
He / She will be responsible for leading, coordinating, overseeing, and providing guidance to the medical teams and other cross-functional team members throughout the organization to guarantee seamless and timely execution of the epidemiology, real-world database studies to support the medical integrated evidence generation strategy.
This person will also participate in the Scientific Review Committee (SRC), Lifecycle Management sub team of the Medical Leadership Team (MLT) and contribute to the parts of Integrated Evidence Generation Plan (IEGP) for product/s they are responsible for.
KEY ROLES AND RESPONSIBILITIES Provide leadership to real world evidence generation to support life-cycle management strategy, identify needs for high value RWE and database studies, and oversee their development, management, and execution. Ensure alignment across clinical trials and HEOR studies. Provide input into novel real world evidence generation opportunities for [the product/s] including identifying novel sources of data and novel approaches to leveraging databases and survey data to support the therapeutic area strategy and improve the understanding of real-world effectiveness of the product . Lead the development of RWE generation including chart reviews aligned with LCM strategic imperatives Develop medical strategies to obtain relevant data evidence from Real World Evidence, consistent with strategic objectives for each product. Ensure that appropriate processes are in place for review, approval, management and support of studies. Provide input to evaluation of investigator sponsored studies and external study collaborations related to real world evidence and database reviews Communicate regularly and timely the product RWE strategy to US Medical & Clinical colleagues and cross-functional team members. Ensure that RWE studies planned fit into the overarching organizational strategy Ensure and oversee the planning, execution and reporting of RWE studies and chart reviews in accordance with established budgets and timelines Monitor performance of RWE activities (e.g. value creation) from conception through publication of database study results and take corrective actions or escalate issues as appropriate. Contribute to continuous improvement of RWE study related processes and best practices. Establish a strong network within the Medical Affairs organization and with other stakeholders namely Marketing, Market Access, HQ R&D, Global Medical Affairs, Clinical Planning, Regulatory, and Pharmacovigilance teams. Partnering with and providing input to Launch/Commercial Team(s) to define RWE strategy to impact the achievement of objectives and maximize the value of each Zymfentra in the franchise. Representing Global Medical Affairs team at medical meetings, advisory boards, outreach meetings at key institutions and/or patient associations, and in interactions with KOLs related to real world evidence generation. Ensure a patient-centric approach to the development of medical strategies for product development as well as possible services which can enhance the value proposition of the product; provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials
WORK EXPERIENCE Advanced degree (e.g. PharmD PhD or M.D.) combined with research background is required along with industry experience working in related areas (e.g. LCM, Clinical Development, HEOR, Epidemiology & RWE, etc.),
preferably related to [Gastroenterology and IBD ]. An MPH is desired but not required. A minimum of 5-7 years experience conducting studies in a pharmaceutical or equivalent environment is strongly desired. Firm working knowledge of GCP, scientific methodology, protocol design, epidemiology, biostatistics, outcomes research, regulatory requirements and compliance for conduct of clinical research are strongly desired.
QUALIFICATIONS Regional or Global experience is highly advantageous. Experience working within an international company with a complex organizational environment; able to operate in a matrix team-oriented structure. Strong understanding of the pharmaceutical/biotech drug development and commercialization process. Able to work on projects in coordination with cross-functional and, where applicable, Alliance partners, and establish excellent working relationships and credibility. Excellent communication and presentation skills with the ability to present scientific data in a credible manner. Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena. Leadership skills: personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances. Collaborative and proactive approach, with a hands-on, roll-up-the-sleeved style and attitude, and sense of urgency is essential Highest integrity; committed to ethics and scientific standards.
EDUCATION Advanced degree in a health science related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry.
CORE COMPETENCIES Knowledge
Oncology, biologics, biosimilars, medical terminology and regulatory requirements. Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Companys products. Collaboration - ability to communicate across functions and at all levels in the organization. Compliance
understands industry regulations to maintain compliance.
Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#LI-DD