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

Position Objectives

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

Position Accountabilities

• 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.
• Lead 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.
• 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

Education, Behavioral Competencies and Skills

• Advanced scientific degree (MD preferred, PhD or PharmD)
• Previous pharmaceutical work experience (minimum 7 years) in Medical Affairs or Clinical Development/R&D or related functions on 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 minimum international 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