Global Medical Lead (GML) Rare Hemostasis
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 (GML) Rare Hemostasis 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.
As a Global Medical Lead (GML) Rare Hemostasis working on the Global Medical Affairs team, you will be empowered to develop and support GPT (launch) strategies and its market development that includes medical tactics to support key strategic imperatives in order to foster successful life cycle management of the related programs.
A typical day will include :
POSITION OBJECTIVES :
Work closely with the cross-functional stakeholders within the hematology franchise.
This role will be a key contributor to maximizing the value of the current established and pipeline RGH Portfolio.
Support the execution of key medical affairs activities of our rare hemostasis portfolio in close collaboration with key functions (eg.
GPL, Clinical Development, Market Access, Regulatory Function, Medical Writing, Publication, and regional and local medical functions) and will lead the GMA activities in all medical aspects, including global medical support of scientific communication and exchange, educational activities, including internal training requirements, support of licensed products and product licensure renewal, support of RA dossier update, RMP development and providing medical support for the geo expansion and market development strategic activities of the related products.
Provide strategic medical support as a GPT core team member and will share medical / clinical expertise with counterparts in other functional areas such as marketing, manufacturing, quality assurance, regulatory affairs, R&D, and abroad.
Current portfolio contains indications as TTP, Sickle Cell disease, von Willebrand Disease, acquired Hemophilia and further pipeline programs.
POSITION ACCOUNTABILITIES :
Develop and support GPT (launch) strategies and its market development that includes medical tactics to support key strategic imperatives in order to foster successful life cycle management of the related programs
Review and provide medical input on licensure renewal, RA filing dossier, medical support for tender submission, Safety and RMP review, PASS study support (as applicable) and other related medical support as further defined
Oversees functional publications, medical communications, medical information and medical training) plans supporting the related programs.
Collaborate with relevant business partners to ensure aligned and medically appropriate established brand strategy, planning and execution
Effective compliant collaborations with internal stakeholders (R&D, commercial, market access, regulatory, clinical development legal, and compliance) and scientific exchanges with external stakeholders (KOLs and HCPs) in alignment with customer needs and medical strategy
Act as a company medical representative to engage external scientific leaders, policy makers, patient advocacy groups and / or regulatory authorities
Develop and maintain knowledge of International pharmaceutical regulations (US / EU, others) and guidelines, codes of practices and Takeda policies related to all medical activities
As directed by the related functions, develop, conduct, or participate in therapeutic training programs for Takeda internal departments
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS :
8 -10 years previous pharmaceutical work experience in Medical Affairs or Clinical Development / R&D
Medical Degree or PharmD
Experience or training in 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 managing 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 and up-to-date knowledge of Takeda products and competitors’ products
In-depth knowledge of pharmaceutical regulations in key markets
This job posting exclude Colorado applicants.
TRAVEL REQUIREMENTS :
30% international travel expected
Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends
WHAT TAKEDA CAN OFFER YOU :
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs