Vice President , Clinical Development Global Head Haemato-Oncology

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary of Job:

The VP Haemato-Oncology is responsible for overseeing the strategic direction  and development of haemato-oncology franchise products in progress. This role entails managing a matrix organization focused on developing and executing Integrated Development Plans (IDPs) leveraging a comprehensive understanding of clinical development processes, particularly in the U.S., Japan and Europe.

The VP will represent the Development function in shaping product strategies for the  global market. This position also involves fostering relationships and engaging in negotiations with projects’ stakeholders- both internal and external- on a global scale. The VP will support teams in the presenting proposals for global development projects governance decision-making meetings, ensuring  timely execution of development plans worldwide.

In addition, The VP Haemato-Oncology will provide medical advice across all Haemato-Oncology programs, and as needed, to other therapeutic areas. This role requires offering strategic guidance on study design, dose optimization strategy, program positioning within the competitive landscape, patient safety and data quality clinical programs at various stages of development. Engagement of external advisors to get their feedback and opinion will be required. This role will work with haemato-oncology development Project Teams ensuring their development as a high-performance teams, ensuring all stakeholders and relevant areas are properly involved.

Essential Functions:

• Oversee matrix organization for haemato-oncology program development, collaborating with key departments (Global Product Strategy, DPSL, CS, PM, CP, TR, CO, CMC, RA) to leverage global leadership effectively.
• Ensure accountability for the reporting of global project plans and progress to internal stakeholders, including the Research/Development Committee, Development Committee, and Global Development Leadership team.
• Provide expert input into protocol development, review informed consent forms and electronic Case Report Forms (eCRFs), assist with protocol implementation, oversee subject safety during studies, and review study data continuously. Participate in the review of other study documents, including statistical plans and data listings, and contribute to the interpretation of study results at completion.
• Support the Global Product Strategy Department in developing Target Product Profiles (TPP) and Life Cycle Management (LCM) plans by providing insights from a development perspective in key markets (Japan, U.S., Europe).
• Collaborate with various functions to ensure the timely delivery of essential outputs aligned with the Integrated Development Plan (IDP), including Clinical Development Plans, Protocol Synopses and Non-Clinical Development Plan, etc.
• Represent haemato-oncology projects as the therapeutic area head at strategic organizational meetings.
• Build strong relationships and facilitate communication with departments such as Corporate Strategy, Intellectual Property, and Corporate Communication.
• Provide medical expert input to Clinical Development Plan and study protocols supporting Clinical Scientists.
• Maintain a comprehensive understanding of the haemato-oncology landscape, staying informed about significant advances and competitive intelligence through relationships with key opinion leaders (KOLs), investigators, scientific literature, and relevant conferences.
• Lead medical input during regulatory meetings, scientific committees and advisory boards, contributing to the creation and facilitation of these discussions.
• Serve as the medical expert for the product and indication area, leveraging insights from prior clinical studies and nonclinical data.
• Mentor and support Project Leaders and Clinical Science Leads in haemato-oncology programs, fostering their professional growth.
• Ensure timely study progression by fostering peer-to-peer communication with clinical investigators.
• Act as a key link providing medical feedback to the Translational Science function, Clinical Pharmacology, Research, and other areas.
• Participate as a medical expert in developing the product publication strategy, ensuring the quality and scientific content of pu