New Product Planning Medical Advisor応募後で応募 求人ID R0065606 掲載日 05/05/2022 Location:Rome, Italy
NEW PRODUCT PLANNING (NPP) MEDICAL ADVISOR
- The position reports to the New Product Planning (NPP) Lead
- The role is based in Italy – Office based (Rome)
- Geographical scope: Italy
- New Product Planning Medical Advisor is responsible for providing medical input into Takeda's new product planning process and for the specific subsequent delivery and execution of Asset Plans for multiple New Molecular Entities (NMEs).
- NPP MA will be a key member of NPP Core Team, focused on pre-launch preparation for medicines which are between 5 and 2 years prior to anticipated launch date in Italy.
- NPP MA will ensure the correct interpretation and communication of scientific data of Takeda NMEs. And will collaborate with and provide relevant input into the LOC NPP Core and LOC Extended Team.
- NPP MA is responsible for NMEs medical planning and execution, including the development of KOL relationships and the identification of potential Italian sites for global studies supporting Global in managing those sites.
- NPP MA will provide medical training to LOC Extended Team members.
- Develop a thorough understanding of therapeutic landscape (current and future), patient pathway (current and future) and disease epidemiology relevant to Takeda's pipeline.
- Provide medical expertise to LOC NPP Extended Team.
- Contribute to undertake asset situation analysis including Global and EUCAN asset plans revisions, previous HUB Assessment review, literature review (international and local data, existing registries and databases).
- Build a personal network of senior KOLs in key therapy areas in order to gain insights on current treatment approaches and areas of unmet need.
- Undertake gap analyses to identify key data gaps which need to be addressed locally in order to address uncertainties as to how best to use medicines and achieve drug access in Italy.
- Plan / support relevant functions to execute relevant evidence generation activities to plug critical data gaps either pre-launch (e.g. epi studies) or immediately post launch (e.g. local registries).
- Provide medical training on new therapy areas to colleagues across the NPP extended Team.
- Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate.
- Present the clinical evidence to internal and external stakeholders in a non-promotional way.
- Assess scientific accuracy and validity of non-promotional material and its compliance with Takeda standards, SOPs and national laws.
- Provide extensive, clear and structured briefing to external presenters/speakers at Takeda sponsored medical events (e.g. local Advisory Boards, doctors’ meetings)
- Provide medical expertise to LOC functions.
- Evaluate and support local investigator initiated research proposals in alignment with global strategy and Takeda standards and SOPs.
- Collaborate with LOC NPP Extended Teem colleagues to build robust Asset plans for relevant New Molecular Entities (NMEs).
- Collaborate with the R&D Clinical Operations team to identify suitable Italian sites for phase IIb / III studies and act as an ongoing Takeda contact point for investigators.
- Collaborate with V&A colleagues to prepare data package for a robust submission to regulatory bodies.
SKILLS and CAPABILITIES
Education and experience:
- Education requirements: Medical Degree Preferred (MD); PharmD or PhD.
- More than 3-5 years of experience in similar medical affairs role.
- Good written and spoken English (minimum level required: Intermediate B1).
- Ability to engage with KOL community based on existing strong relationships and help to build lasting relationships with KOLs.
- Thorough understanding of life cycle management.
- Experience with working in pre-launch phase, launch preparations, especially in rare diseases and/or orphan disease markets.
- Ability to interpret and communicate scientific/ clinical data.
- Ability to work in a cross functional team and evidence of building cross-region networks.
- Strong business acumen.
- Proactive and positive work ethic.
- Confident and enthusiastic.
- Ability to operate as a flexible team player.
- Thorough attention to detail.
- The role will involve both national and international travel.
- Valid and clean driver’s license.