Global Medical Lead, Hematology

Vor 2 Tagen

Wien, Österreich Takeda Pharmaceutical Vollzeit

Objectives:

- Lead execution of key PDT Global Medical Affairs activities according to the PDT GMA strategy in close collaboration with global key functions and will lead global scientific programs and clinical related activities.
- Strategically support the GPT, Clinical Development, Research, Quality, Safety and Regulatory throughout - providing medical and technical support.
- Shares medical/clinical expertise with his/her counterparts in other functional areas such as GPT, R&D, Manufacturing, Quality, Safety, Regulatory Affairs and Legal.
- Provide medical review to global promotional and non-promotional materials
- Act as a company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
- Establish appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
**Your Opportunity**:

- Contribute to the development and implementation of the division's long and short-term business strategies to optimize markets for future and current products and development of rational strategic plans for profiling and indication expansion of licensed products.
- Provide input into clinical research strategy and conduct of Phase IV clinical trials for licensed products and gives input on new product development for successful launch into the marketplace.
- Provides support for activities related to the evaluation and investigation of adverse events related to licensed products.
- Planning, designing and managing global medical Advisory Boards including working with vendor(s) to ensure timely submission and approval
- Actively track, enter and manage KOL engagement activities in KOL engagement platform
- Function as the medical/clinical representative at global regulatory meetings that pertain to product development activities for which the incumbent has responsibility.
- Provide medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the regulatory authorities regarding various issues such as Package Insert, Patient Information, etc.
- Work with product development and marketing functions to define the requirements and specifications for new products.
- Review all product complaints that have resulted in adverse clinical consequences or could potentially have results in adverse clinical consequences to determine if corrective actions are necessary. Recommend corrective actions in consult with Quality, Regulatory, Medical Director.
- Maintain knowledge base as to developments and trends in medical sciences.
- Contribute to the training, leadership and continuing education for cross-functional partners, eg. global medical affairs and GPT departmental staff.
- Develop/support development of global medical plans and strategies that include tactics to support key strategic imperatives for the disease area / brand(s) in both pre
- and post
- launch setting.
- Develop/support in-year medical tactical plan and budget for global initiatives and where applicable, collaborate with local initiatives.
- Oversees functional (e.g. publications, medical communications, medical information and medical training) plans supporting global medical strategies.
- Collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution.
- Participate in product development strategy and provide medical affairs and R&D inputs.
- Act as a company medical representative to engage external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities.
- Establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders.
Establish appropriate partnerships with KOLs in areas of scientific interest.
- Represent Global Medical Affairs at internal and external meetings.
Present data on PDT Hematology product portfolio / disease area at internal and external meetings.
**Your Skills and Qualifications**:

- Advanced scientific degree (MD, PhD or PharmD)
- Previous pharmaceutical work experience in Medical Affairs or Clinical Development/R&D or related functions
- Experience or training in benign Hematology and bleeding disorders
- Experience in Medical Affairs function with focus on supporting brands or disease area at country, regional or global level
- Experience in creating post-approval studies, medical strategies and launch plans
- Good understanding of critical processes in R&D in pharmaceutical environment (eg. drug development and approval, clinical trials and investigator-initiated trial processes)
- In-depth knowledge of pharmaceutical regulations in key markets

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rot

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