The Global Medical Lead TTP and SCD (TAK755) will develop and execute the medical scientific development strategy, pre-launch planning and global medical launch planning for rADMATS13 (TAK755) in close collaboration with the GPT TAK755.
- Work with the GMTL and other GMLs to develop and execute multi-year global medical strategy alignment for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional Strategies (clinical, regulatory, HEOR, PV, compliance)
- Work with the GMTL on the development and in-year implementation of the medical plan globally and/or support in year plan definition and implementation by US GD TA team
- Supports execution of specific medical projects per global medical strategy
- Serve as Hematology Medical representative on standing and project-based cross-functional teams
- As needed provide medical review to 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 center of excellence and KOLs in areas of scientific interest
Support the development of global medical strategy and plans with alignment with Global Medical Team.
- Work with GMTL and Global Franchise and Product Leads to develop global medical plans that include tactics to support key strategic imperatives for the disease area/band in both pre- and post-launch setting
- As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical information and medical training) plans supporting global medical strategy with alignment with Global where applicable
- As delegated by the GMTL, collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution
- As delegated by the GMTL, participate in product development strategy and provide medical affairs and R&D inputs.
Implementation in-year global medical strategy
- As delegated by the GMTL, directly implement plans and collaborate with Global Franchise and Product Leads, potentially including:
- Development and implementation of medical pre- and post- launch plans for late-stage pipeline products or product label expansions
- Providing medical leadership for scientific communications, including core scientific statements, standard responses, Phase IV plans and publications
- Planning, designing and managing or participating in local, regional, national and global medical Advisory Boards including working with vendor(s) to ensure timely submission and approval in RnD select
- Providing medical review of Investigator Initialed Research (KKR) proposals and other grans through the grant approval process
- Managing the design and execution of clinical studies (phase IIb/IV, disease registries, HEOR studies, outcomes surveys, etc.)
- Monitoring and communicating progress against medical plan; propose and implement initiatives as needed to adjust to disease area requirements
- Conducting and ensuring timely medical review and approval of promotional and meeting materials as required per SOP
- Serving as Hematology Medical respresentative on standing and project-based cross-functional teams Serving as Global Medical respresentative on standing and project based cross-functional teams.
Effective compliant collaborations with internal stakeholders (R&D, commercial, marketing, regulatory, legal, and compliance) and scientific exchanges with external stakeholders (KOLs and HCPs) in alignment with customer needs and medical strategy
- Act as company medical respresentative to engage external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities
- Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key academic institutions and develop relationships with key thought leaders
- Per medical strategy, establish appropriate partnerships with KOLs in areas of scientific interest
- Represent Medical Affairs in internal and external meetings and present data on product/disease area
Education and Experience
- A Doctor Degree in Medicine, (MD), PhD or PharmD is required.
- 8-10 years of related work experience in industry, clinical or research institution, preferably in Genetics, Metabolic or Hematology
- Experience in Medical Affairs particularly Hematology is preferred
- Experience in supporting brands or disease area levels in country regional or global organizations if preferred
- Experience in other relevant disease areas of interest though clinical experience, bio-pharmaceutical experience or education may be considered.
Key Skills and Abilities
- Demonstrated business acumen and operational skills
- Ability to think strategically and tactically from a medical perspective about how to medically appropriately support the growth of the brand
- Ability to work in a Global mindset environment, across diverse cultures
- Ability to collaborate appropriately with Commercial functions
- Ability to represent company s interest in scientific forums as needed
- Excellent written and verbal communication skills
- Ability to manage teams and drive initiatives
- Results orientation and accountability
- Good analytic skills as applied to medical, scientific and technical information
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