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- 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, abilities & experience
- MD with 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
- Board eligible or certified Oncologist preferred
- 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. Additional
- Appropriate skills and flexibility for leading teams in a very dynamic, cross-functional environment
- Experience in development programs preferred
- Knowledge of Phase IV program development and specifically management of observational studies
- Ability to develop and maintain credible relationships with top tier experts in Rare Disease and Physical Medicine and rehabilitation; existing network of such relationships preferred
- Highly developed interpersonal skills and demonstrated people leadership in similar position(s)
- Demonstrated awareness of regulations governing promotional activities; highly developed sense of ethics
- Articulate in oral and written communication; skilled at communicating scientific information in simple format
- Ability to travel – 35% is required
- Excellent planning and organizational skills
- Presentation, Facilitation and Instructional skills
- Works independently and with cross functional teams
- Prior Business development experience in evaluation of Oncology assets Ipsen US Pay Range Disclosure Language The annual base salary range for this position is $270,000-$396,000. This job is eligible to participate in our short-term incentives program as well as our long-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
VP & Head, Medical Affairs, Oncology - Cambridge Springs, United States - Ipsen Biopharmaceuticals, Inc.
Description
Title:VP & Head, Medical Affairs, Oncology
Company:Ipsen Biopharmaceuticals Inc.
Job Description:
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 lead a team of 30 + people, including medica leads and medical directors, a publication and communications, External Scientific Collaborators and Field Director(s) overseeing 19 MSLs.
Main responsibilities / job expectations
Responsibilities will include, but are not limited to, the following:
Global Asset responsibilities