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 publication team outputs.
• Organize and conduct critical reviews of competitor intelligence, taking action based on findings.
• Represent Kyowa Kirin’s interests in projects, presentations, communications and engagements with external partners as appropriate.

Education:

MD or MD/Ph.D. with a specialty in Hematology or Oncology. Board certification (or equivalent) in medical oncology/hematology is required.

Requirements:

• Minimum of 10 years in the pharmaceutical industry with a strong focus on hematology and/or oncology therapeutic areas.
• Proven experience in working with regulatory agencies, including the preparation of regulatory documents at various stages of development (e.g., IND, NDA).
• Comprehensive understanding of multiple functions within drug development and their contributions to business objectives.
• Strong global team leadership with capacity to effectively work in a multinational environment.
• Skilled in establishing clinical development best practices through strong cross-functional partnerships within a matrix organization.
• Excellent communication skills to coordinate with various functions, combined with strong decision-making abilities to guide teams toward strategic goals.
• Ability to facilitate transparent and regular communication with internal and external stakeholders, while managing reports across different time zones.
• In-depth and profound understanding of the complete global drug development process.
• Advanced knowledge in Haemato-Oncology, with a proven track record of innovating clinical trial designs, providing relevant evidence for decision-making, and adeptly interpret and present program-level clinical trial data.

Technical Skills:

• Expertise knowledge of FDA/EMEA requirements, good clinical practices and pharmaceutical clinical development in oncology.
• Solid experience using Microsoft Office Suite including Outlook, Project, Excel, Power Point and Word.
• Strong written, verbal, interpersonal and listening communication skills: articulate and effective communicator and presenter, able to describe complex problems and solutions in understandable terms; Ability to take complicated medical or scientific concepts and effectively communicate them to a range of audiences.

Non-Technical Skills:

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quicklyStrong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization. Ability to travel up to 30% to clinical study sites, meetings, etc.

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.

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

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