Senior Medical Director, Project Lead, Hematology-Oncology

Job Purpose

The Project Lead Medical Director / Sr Director Hematology-Oncology is responsible for develop, oversee, and maintain Integrated Development Plan (IDP) for designated development projects, drawing on a solid grasp of the clinical development processes, particularly in the U.

S. Japan and Europe. Additionally, assume responsibility for representing Development in the definition of product strategies tailored for the global market.

He / she should also foster relationships and engage in negotiations with project stakeholders, both internally and externally, from a global standpoint, presenting proposals for global development projects at Development governance decision-making meetings, securing timely execution of development plans globally.

He / she should provide medical advice in general to all Hematology-Oncology programs or other therapeutic areas as needed.

His / her feedback and advise on study design, dose optimization strategy, positioning of programs considering competitive landscape, patient safety and data quality for other clinical programs at different stages of development, as well as support engagement of external advisors to get their feedback and opinion will be required.

This role will lead the Project Team ensuring the team developing it as a high-performance team, ensuring all stakeholders and relevant areas are properly involved.

Key Responsibilities :

• Oversee IDP aligned to global product strategy / Target Product Profile (TPP) in collaboration with the relevant departments (Global Product Strategy, CMC, TR, RA, etc) leveraging global leadership.
• Report global project plans and progress to internal stakeholders (e.g. Research / Development Committee, Development Committee, Global Development Leadership team) with firm knowledge on global environment.
• Confirm deliverables from each function aligning with IDP (e.g. Clinical Development Plan, Protocol synopsis, Non-clinical Development Plan, etc.)
• Support GPSD develop TPP or LCM plans by providing insights from development perspectives in relevant countries (Japan, the U.S., and Europe)
• Communicate with other departments (e.g. Corporate Strategy, Intellectual Property, Cooperate Communication, etc.) by building strong relationships
• In the partnering projects in charge, communicate and engage with partners, representing Kyowa Kirin’s best interests.
• Provide expert input into protocol development, review informed consent and eCRF; assist operations in the implementation of protocols;

oversee subject safety during the conduct of the study and review data on an ongoing basis during study conduct. Review other study documents i.

e statistical plan and data listings and participate in interpretation of study results at completion.

• Provide medical expert input to Clinical Development Plan and study protocols supporting Clinical Scientists.
• Have a very high level, clear and broad perspective on the therapeutic area and be aware of important advances within that area (including competitive intelligence), through relationships with KOLs, investigators, the scientific literature and attendance at critical meetings.

Be able to communicate this perspective appropriately.

• Lead Medical input to regulatory meetings and at scientific committees and advisory boards, participating on the creation of them and facilitating its functioning.
• Represent the product and indication area internally and externally as the medical expert based on proper understandings on earlier clinical studies and nonclinical data of the product.
• Support timely study progress in cooperation with Clinical Operation through peer-to-peer communication with the investigators.
• Provide Medical feedback as key link to Translational Science function and Clinical Pharmacology
• Participate as Medical expert on development of product publication strategy, plus the medical scientific content and quality of publication team outputs
• Present on behalf of projects / Kyowa Kirin as appropriate
• Organize and appraise critical review of competitor intelligence and act accordingly

Position Requirements :

Education

MD, with specialty in Hematology or Oncology

Experience

At least 10 years of experience within the pharmaceutical industry and therapeutic area knowledge in hematology and / or oncology.

• Experience working with regulatory agencies, preparing regulatory documents at different stages of development (i.e IND, NDA etc)
• A high-level understanding of more than one function and how they contribute to drug development and ultimately to achieving the objectives of the business
• Global leadership : Strong Global team leadership skills and a capacity to work effectively in the global environment
• Development of clinical development best practices by building firm cross-functional stakeholder partnerships in a matrix organization
• Communication skills to coordinate with other functions and decision-making skills to lead the team to the right direction are essential
• Facilitate transparent / regular communication with internal / external stakeholders and manage reports across time zones
• Profound understanding of the complete global drug development process.
• Advanced knowledge in Hematology-Oncology, demonstrating the ability to innovate in clinical trial designs, provide pertinent evidence for decision-makers, and adeptly interpret and present program-level clinical trial data

Non-Technical Skills

Strong oral and written communication skills needed. Need to be a cooperative member in clinical development team. Ability to multi-task.

Physical Requirements :

The role is office based and requires approximately 20% domestic and international travel as needed.

Key Competencies specific to the role :

• Excellent oral and written communication skills needed
• Excellent analytical and organizational skills
• Excellent clinical and scientific judgment
• Cross functional / cross cultural / global working experience

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions