Medical Director, CPED PDT応募後で応募 求人ID R0066311 掲載日 05/03/2022 Location:Boston, Massachusetts
The Takeda PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. The incumbent of this Medical Director role will provide strategic support and oversight of early clinical programs in the PDT R&D taking into consideration the medical, scientific, regulatory and commercial issues. This individual will lead multiple clinical pharmacology and early phase clinical studies in healthy subjects or patients, and is expected to apply clinical/medical decision making to eraly clinical development issues.
Act as the Medical lead for Early Clinical Development programs on cross-functional, multiregional, matrix project teams and/or clinical subteams. Participate in the development of early clinical development plan to support the transition of new product candidates from preclinical to first in human to Phase 2a, as well as product life cycle management strategies. Work with other functional disciples to ensure the full scope and remit of early clinical development is represented as needed within clinical study teams. Partner with Translational Research and Global Clinical Lead as needed to ensure that translational medicine plans are enabled in relevant therapeutic area programs. Lead/participate on cross-functional team to conceptualize clinical pharmacology and early phase clinical studies in healthy subjects or patients, and drives the synopsis/protocol development. Act as the Clinical Lead and Medical Monitor during the execution phase of studies. Serve as technical resource for clinical issues raised by internal and external collaborators and investigators. Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Conducts data review, analysis, and interpretation of clinical trials data together with the Global Clinical Lead, Clinical Safety, Biostatistics and other relevant functional leads.
Support the development and review of clinical and regulatory documents, including clinical development plan, IND, regulatory briefing book, Annual Report, investigator brochure, statistical analysis plan and others. Represent Clinical Pharmacology & Early Clinical Development in the relevant interactions with regulatory agencies as well as advisors/experts in the related therapeutic areas.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MD, MD/PhD or internationally recognized equivalent degree with >5 years of clinical research/drug development experience within the pharmaceutical industry, CRO healthrelated consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Previous experience in early clinical development with clinical trial experience in clinical pharmacology and early phase clinical studies is required. Experience in regulatory interaction and submission is desired. SKILLS Excellent communication and scientific writing skills and working experience on matrix teams are required. Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate. Excellent strategic, interpersonal and negotiating skills Ability to proactively predict issues and solve problems Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams Diplomacy and positive influencing abilities across multinational business cultures KNOWLEDGE Knowledge in Immunology, Immunodeficiencies, Neurology, Pulmonology or related specialties relevant to disease mechanisms and plasma derived/related therapies Board certification/s in related specialty areas is desired Good understanding of Clinical Pharmacology principles and PK/PD knowledge is highly recommended. Experience in biologics and familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences) is preferred. Regional/global Regulatory requirements GCP/ICH Emerging research in plasma derived/related therapies
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
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