Senior Medical Director, Oncology/Hematology

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary of Job:

The Senior Medical Director, Oncology/Hematology provides strategic leadership within the medical aspects of  our clinical development programs.  Major areas of responsibilities include providing medical advice within the therapeutic areas of Oncology/Hematology, participate in specific projects including indications, study design, dose optimization strategy, positioning of programs considering competitive landscape, patient safety and data quality for early and late phase clinical trials.  This role will work as part of the Study Team to ensure medical expertise is provided to the projects, integrity of the studies is kept, ensuring medical decision on study conduction are appropriate (i.e. subjects enrolled meet the study criteria) and work with the investigators to ensure high level standard for study conduction and subject safety in addition to support timely study progress. This role will also support Clinical Scientists to ensure the successful design and implementation of Clinical Development Plans.

• 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 inputs 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
• Participates 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

Education

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

Experience

• Minimum seven (7) years’ experience within the pharmaceutical/biotech industry and therapeutic area expertise in hematology and/or oncology.
• Minimum three (3) years demonstrated managerial, organizational, and leadership experience in a dynamic environment running multiple clinical studies.
• Completion of medical training, such an internship and residency program after medical school, and obtained board certification and a license to work in a medical setting.
• Must be able to demonstrate a strong understanding of clinical development, early development experience highly preferred.
• Proven experience working with regulatory agencies, preparing regulatory documents.
• Strong understanding of one or more scientific/clinical discipline that is relevant to drug development.
• Extensive knowledge of the workings of and challenges faced by the pharmaceutical industry.

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 an