Associate Medical Director, Global Clinical Science (CVM) Takeda Pharmaceutical - Deerfield, IL, US The Associate Medical Director leads and drives strategy for the overall regional (US/EU) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compound(s). Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products. Accountabilities Clinical Development team participation and leadership •Represents Clinical Science on US/EU Development Teams and will serve as leader of this team. Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy. May act as Global Development Team (US, EU, Japan) Leader managing both the US/EU Development Team and the Japan Development Team for an early or a smaller scope product. •Responsible for development team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Ongoing work output will involve 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. Recommends high impact global decisions. Responsible for 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. 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 •Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines how individual study results impact the overall compound 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 compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues. •Makes final decisions regarding study conduct related to scientific integrity. External Interactions •Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Provides leadership in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate. Due Diligence, Business Development and Alliance Projects •Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans. •Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. For ongoing alliance projects, will interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Leadership, Task Force Participation, Upper Management Accountability •Interacts with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. Represents clinical science and leads internal task forces and TGRD internal teams as well as global cross-functional teams as appropriate. •Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. Job Posting Aug 28, 2014, 3:51:42 PM Education, Experience And Skills •MD or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). •Previous experience successfully leading matrix teams preferred. •Management experience preferred Skills •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 •Therapeutic area knowledge relevant to mechanism of action •Regional/global Regulatory requirements •GCP/ICH •Emerging research in designated therapeutic area Travel Requirements •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.
Posted on: Sat, 08 Nov 2014 20:49:28 +0000
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