Ipsen
Vice President & Head US Medical Affairs, Oncology
Ipsen, Cambridge, Massachusetts, us, 02140
Vice President & Head US Medical Affairs, Oncology
2 days ago Be among the first 25 applicants
The VP, Head of Medical Affairs, Oncology, will be a strategic partner for the assets under his/her responsibility, and will lead a dynamic US-based group overseeing the medical strategy and operational execution of all the multiple functions and therapeutic indications for all marketed products, products in development and provide expertise in business development, as required. As part of the responsibilities, this person will also oversee all life cycle management activities related to on‑going Phase IV studies, as well as to closely interact with the R&D team and global medical teams to support registrational trials or global medical affairs sponsored trials. This individual will collaborate with a team of more than 30 professionals, including medical leads, medical directors, publication and communications teams, external scientific collaborators, and Field Directors overseeing 19 MSLs, to lead the strategy and execution of Medical Affairs Oncology initiatives.
Global Asset Responsibilities
Provide input and influencing the global therapeutic area and each asset strategy, by providing expertise and ensuring strategic alignment between the US and the Global Medical Oncology
Oversee and ensure alignment with the US medical lead as member of the Asset Team and the Global Oncology Medical team
Build the evolution of the global and US business strategy to expand on the increasing number of assets and impact to the overall organization
Accountable for preparing arrival of new assets, from input into business development to contribution to registration studies, when required and preparing the strategy and organizational readiness and team structure ready for launch
Ability to influence internal and externally, manage and navigate complexity and display of leadership skills across the organization
Direct all the activities in US medical affairs, which include:
Build, update and maintain the US organization for the therapeutic area according to the strategic business needs
Lead the medical strategy and medical planning for US NA Oncology Ipsen products.
Medical Directors for Clinical Studies and Early Access programs in the therapeutic area.
Develop in-depth knowledge of Ipsen’s programs in order to support and facilitate integration of evidence portfolio into grey literature, medical publications, presentations at scientific meetings, and other forms of external communications.
Coordination and development of appropriate medical plans in collaboration with global medical affairs and other relevant internal partners
Oversight of the Phase IIIb/IV US studies, Investigator Sponsored Studies and R&D studies with US involvement in close collaboration with the global R&D and medical affairs teams
Accountable for the development and communication of appropriate publication plans
Oversight of all publications including posters, abstracts, manuscripts both at the US and global level to ensure appropriate alignment between relevant teams
Development of appropriate HEOR plans, supervision of on‑going data generation projects as well as responsible to provide guidance for new projects
Frequent communication with the MSL team via the US MSL Leads. Ensure appropriate and timely training on new data is provided to the team, support answering questions from the team
Lead and oversee the management of relationships with health care professionals and professional organizations, patient advocacy groups, and educational foundations.
Represent the medical function for review and approval of communication materials according to corporate and government/industry standards and regulations.
Build and manage the medical information function.
Lead the review, approval, and implementation of investigator‑initiated study activities.
Support the development and implementation of Ipsen oncology assets across managed access programs.
Knowledge & Experience (essential)
10 years of pharmaceutical industry experience and a minimum of 5 years of experience in Medical Affairs in solid and hematological tumors
3 years minimum experience in the US
Prior experience in developing medical plan strategies
Ability and ease in cross‑functional alignment with global medical, Research & Development, Commercial and Regulatory teams
Proven effective managerial oversight of a medical affairs team representing different functions
Extensive knowledge and experience in Oncology
Knowledge and expertise in HEOR, scientific publications, Clinical Operations and MSL role remit
Experience and excellent presentation skills and publishing/review of scientific information a must
Knowledge of clinical trial design, execution, and biostatistics
Expertise and knowledge of the unique aspects of oncology drug development and commercialization
Understanding of North American and Global regulatory framework for oncology product development and commercialization, including reimbursement negotiations
Experience in analyzing, interpreting and reporting scientific results of clinical studies
Demonstrated ability to summarize and present complex medical data to different audiences, including patient groups, scientific meetings and regulatory bodies
Education / Certifications
Advanced degree in a scientific discipline (MD preferable)
Board eligible or certified Oncologist preferred
Language(s) (essential)
Fluent in English.
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The VP, Head of Medical Affairs, Oncology, will be a strategic partner for the assets under his/her responsibility, and will lead a dynamic US-based group overseeing the medical strategy and operational execution of all the multiple functions and therapeutic indications for all marketed products, products in development and provide expertise in business development, as required. As part of the responsibilities, this person will also oversee all life cycle management activities related to on‑going Phase IV studies, as well as to closely interact with the R&D team and global medical teams to support registrational trials or global medical affairs sponsored trials. This individual will collaborate with a team of more than 30 professionals, including medical leads, medical directors, publication and communications teams, external scientific collaborators, and Field Directors overseeing 19 MSLs, to lead the strategy and execution of Medical Affairs Oncology initiatives.
Global Asset Responsibilities
Provide input and influencing the global therapeutic area and each asset strategy, by providing expertise and ensuring strategic alignment between the US and the Global Medical Oncology
Oversee and ensure alignment with the US medical lead as member of the Asset Team and the Global Oncology Medical team
Build the evolution of the global and US business strategy to expand on the increasing number of assets and impact to the overall organization
Accountable for preparing arrival of new assets, from input into business development to contribution to registration studies, when required and preparing the strategy and organizational readiness and team structure ready for launch
Ability to influence internal and externally, manage and navigate complexity and display of leadership skills across the organization
Direct all the activities in US medical affairs, which include:
Build, update and maintain the US organization for the therapeutic area according to the strategic business needs
Lead the medical strategy and medical planning for US NA Oncology Ipsen products.
Medical Directors for Clinical Studies and Early Access programs in the therapeutic area.
Develop in-depth knowledge of Ipsen’s programs in order to support and facilitate integration of evidence portfolio into grey literature, medical publications, presentations at scientific meetings, and other forms of external communications.
Coordination and development of appropriate medical plans in collaboration with global medical affairs and other relevant internal partners
Oversight of the Phase IIIb/IV US studies, Investigator Sponsored Studies and R&D studies with US involvement in close collaboration with the global R&D and medical affairs teams
Accountable for the development and communication of appropriate publication plans
Oversight of all publications including posters, abstracts, manuscripts both at the US and global level to ensure appropriate alignment between relevant teams
Development of appropriate HEOR plans, supervision of on‑going data generation projects as well as responsible to provide guidance for new projects
Frequent communication with the MSL team via the US MSL Leads. Ensure appropriate and timely training on new data is provided to the team, support answering questions from the team
Lead and oversee the management of relationships with health care professionals and professional organizations, patient advocacy groups, and educational foundations.
Represent the medical function for review and approval of communication materials according to corporate and government/industry standards and regulations.
Build and manage the medical information function.
Lead the review, approval, and implementation of investigator‑initiated study activities.
Support the development and implementation of Ipsen oncology assets across managed access programs.
Knowledge & Experience (essential)
10 years of pharmaceutical industry experience and a minimum of 5 years of experience in Medical Affairs in solid and hematological tumors
3 years minimum experience in the US
Prior experience in developing medical plan strategies
Ability and ease in cross‑functional alignment with global medical, Research & Development, Commercial and Regulatory teams
Proven effective managerial oversight of a medical affairs team representing different functions
Extensive knowledge and experience in Oncology
Knowledge and expertise in HEOR, scientific publications, Clinical Operations and MSL role remit
Experience and excellent presentation skills and publishing/review of scientific information a must
Knowledge of clinical trial design, execution, and biostatistics
Expertise and knowledge of the unique aspects of oncology drug development and commercialization
Understanding of North American and Global regulatory framework for oncology product development and commercialization, including reimbursement negotiations
Experience in analyzing, interpreting and reporting scientific results of clinical studies
Demonstrated ability to summarize and present complex medical data to different audiences, including patient groups, scientific meetings and regulatory bodies
Education / Certifications
Advanced degree in a scientific discipline (MD preferable)
Board eligible or certified Oncologist preferred
Language(s) (essential)
Fluent in English.
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