The 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 Head, Clinical Medicine, Plasma-Derived Therapies Business Unit will have the ability to create and define the future vision and operating model for the team. There will be two main drivers of innovation in the newly-formed PDT R&D group:
- Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It will combine translational research with pharmaceutical sciences and device, and will receive inputs from and into clinical research and manufacturing sciences.
- Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.
The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development in partnership with others, taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda PDT BU pipeline and inline products. Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership centrally, regionally, and locally. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences PDT R&D leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.
- Clinical Development team participation and leadership
- Leads Clinical Development for a given product and/or indication, and may represent Clinical Medicine on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.
- Establishes and drives development team strategy and deliverables producing the development strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to assoc. med directors and clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall product strategy
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Trial Medical Monitoring
- Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and products in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
- Makes decisions regarding study conduct related to scientific integrity.
- External Interactions
- Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D. Provides leadership and serves as an advisor to the others engaged in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
- Due Diligence, Business Development and Alliance Projects
- Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
- Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D s strategic goals while striving to maintain good working relationship between Takeda PDT BU and partner. Provides guidance to others who are involved in some of these activities.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. May represent clinical science on high impact/priority task forces across the organization or external to the company. May lead PDT R&D internal teams and global cross-functional teams, as appropriate.
- May hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning, as appropriate.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned).
- Previous experience successfully working in a clinical development team/matrix team with responsibility for studies in multiple regions.
- NDA/MAA/Submission experience preferred
- Management experience
- Superior communication, 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
- Knowledge/experience in Hematology or related specialties relevant to disease mechanisms and plasma derived/related therapies
- Regional/global Regulatory requirements
- Emerging research in plasma derived/related therapies
- Physician and Surgeon Medical License or equivalent
- Board certification/s in Hematology is desired
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10 - 20% travel.
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