Global Medical Lead, PDT Hematology (f/m/x)

Takeda

1d•$192,400 - $302,390•Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our Cambridge, MA office. 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. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

Requirements

Advanced scientific degree (MD preferred, PhD or PharmD)
Minimum 7 years of previous pharmaceutical work experience in Medical Affairs or Clinical Development/R&D or related functions on a minimum international level
Experience or training in benign Hematology and bleeding disorders
Experience in Medical Affairs function with focus on supporting brands or disease area at a minimum international level
Experience in creating post-approval studies, medical strategies and launch plans
Good understanding of critical processes in R&D in the pharmaceutical environment (e.g., drug development and approval, clinical trials, and investigator-initiated trial processes)
In-depth knowledge of pharmaceutical regulations in key markets

Responsibilities

Lead execution of key Global Medical (GM) activities for Prothromplex according to the PDT Benign Hematology GM strategy in close collaboration with global key functions.
Define and lead development global medical launch strategy for Prothromplex and subsequent scientific programs and related medical activities.
Strategically support the GPT, Research & Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout - providing medical and technical support.
Provide medical review to global promotional and non-promotional materials
Act as a company representative in supporting activities with external scientific leaders, patient advocacy groups and/or regulatory authorities
Support establishments of appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
Lead the development and implementation of the division's short and long-term business strategies (scientific communication strategy, evidence generation strategy, capability building strategy and KOL engagement plan) to optimize markets for future and current products and development of rational strategic plans for profiling and indication expansion of licensed products.
Lead development of global medical plans and pre-launch and launch strategy that include tactics to support key strategic imperatives for the disease area / brand(s) in both pre- and post- launch setting.
Develop 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.
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 support 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.
Supports 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.
Lead strategic direction for capability building and partner closely with the training department, leadership and continuing education for cross-functional partners, eg. global medical and GPT departmental staff.
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 at internal and external meetings.
Present data on Benign Hematology product portfolio / disease area at internal and external meetings.
Supports clinical research strategy and lead complimentary evidence generation strategy, including but not limited to 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.
Partner with inhouse DD&T and incorporate AI-driven projects into the strategic execution