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:
The Director, Clinical Science Lead, Hemato-Oncology, is a vital position in our growing global organization. As part of the Clinical Science group, this person is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e.g., IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from clinical perspective, deep dive into the science of our oncology programs and play as a subject matter expert in hemato-oncology. He/she will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for new and/or launched oncology products development including lifecycle management. He/she will be responsible for establishing and maintaining KOL relationships.
Essential Functions:
• Represent the Clinical Science team in project teams in hemato-oncology area and serve as the leader of the team based on firm understandings of hemato-oncology disease area and clinical development/trial process especially in the US and Europe.
• Lead the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly.
• Lead the formulation of clinical trial protocols with sufficient feasibility and high probability of success based on expertise in hemato-oncology area.
• Support/lead development of written material for clinical sections of key regulatory submissions; interface with regulatory authorities in each country to provide support for regulatory submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
• Provide input from the clinical perspective to the formulation of Target Product Profiles.
• Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required
• Support required safety evaluations for clinical studies, e.g. AE assessment, as needed.
• Perform close oversight of work performed by external medical monitors involved in group’s clinical studies.
• Maintain knowledge of scientific developments in field and activities of competitors.
• Create and maintain good relationships with Key Opinion Leaders in hemato-oncology area and clinical investigators; identify physicians with potential to serve as strong investigators for clinical studies.
• Attend relevant scientific meetings to strengthen competency in hemato-oncology field and to gain awareness of research activities underway.
• Lead and author the publications and meeting presentations of clinical trials and review articles.
• Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).
• Perform other duties, as required.
Requirements:
Education
MD, combined MD/PhD, or relevant clinical or biomedical Ph.D. A degree in science, pharmacy, nursing, or MSc with significant, applicable R&D experience may also be considered.
Experience
• Minimum of eight (8) years of pharmaceutical industry experience with a minimum of three (3) years in clinical development; significant comparable experience outside of pharmaceutical industry may be considered.
• Significant experience and ability to work effectively with external partners, including physicians and vendors.
Technical Skills
• Strong scientific background with good understanding of drug development process
• Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills.
• Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a multinational organization.
• Excellent written and oral communication skills
• Good project management skills; able to organize and prioritize multiple activities.
• Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats.
• Ability to think analytically (strategically and tactically) and simultaneously consider scientific, medical, and business aspects of projects.
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.
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