Posted to MedZilla on 3/29/2017


Takeda Pharmaceuticals

US-MA, Executive Medical Director Marketed Products & Vaccines 1602337-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. As a global, research and development-driven pharmaceutical company, Takeda Pharmaceutical Company Limited conducts R&D both internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology and central nervous system, plus vaccines. Novel products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

Responsible for the leadership and oversight of major and complex therapeutic areas. These include multiple complex development programs that can be grouped in more than one specialty therapeutic areas (such as CV/Metabolic or Internal Medicine, etc.), or a large scale homogenous therapeutic area that consists of multiple complex programs. The Executive Medical Director (EMD) is also responsible for management of physicians who serve as the Global Safety Leaders (GSL) for both developmental and marketed compounds in designated therapeutic area and may act as a GSL. The EMD will also manage Senior Medical Directors who may oversee a single therapeutic area (such as Diabetes, or CV, etc). The EMD will interact with and influence other TDC departments (Clinical Operations, Regulatory affairs, Analytical Science, Clinical Science, etc.) to ensure the successful development, design and implementation of comprehensive safety assessment protocols for both developmental and marketed products. The EMD will oversee and manage signal detection and risk management activities undertaken by the GSLs and ensure that both developmental and marketed compounds have a comprehensive safety assessment plan in situ. Further, this position will oversee and manage the reactive response to any new safety signal/crisis, although the primary responsibility will reside with the GSL. The position holder will have a pivotal role in managing contributions/presentations to Safety Board and similar forums.

ACCOUNTABILITIES:

  • In conjunction with VP Global Safety and other functions within Global Pharmacovigilance will ensure effective functioning of the department including strategic and long-term planning and resource assessments
  • In conjunction with VP Heads Global Safety and relevant PV and extra PV disciplines, including Regional Head of PV will lead and coordinate interpretation of safety data from internal and external studies/sources and communicate at senior leadership level the impact of same both in terms of go/no go decisions or modification of development plan or study design, including potential impact on timeline or product labeling
  • Responsible for reviewing, analyzing and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuing scientific and medical implications. Further, coordinating/leading recommendations derived from new safety data for developmental compounds and marketed drugs, ensuring the primacy of patient safety.
  • Leads along with colleagues in allied Safety Functions the development of a global consensus on signal detection tools and activities
  • As one of the most senior physicians in PV Medical Safety will mentors other PV physicians for developmental compounds and market drugs, safety monitoring and risk management assessment and analysis.
  • Responsible for presentations to Safety Board and similar forums and will help facilitate cross functional interactions (within and outside Global PV) for same. As appropriate the position holder will directly involve himself/herself in presentations to Safety Board, recognizing that this will primarily reside with the GSL.
  • Will ensure that he/she ensures follow up to request from Safety Board
  • Attends corporate committees such as the Therapeutic Area Teams and Development Review Committee representing the assigned therapeutic area(s).
  • Oversees the medical safety evaluation of projects by the PV physicians for new business development opportunities (e.g., due diligence evaluations).
  • Directs PV interactions with Regulatory authorities
  • Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
  • In conjunction with Global Risk Management and Pharmacoepidemiology oversee risk management plans for compounds in development and market drugs
  • Ensures that PV physicians are proactively identifying safety concerns and developing contingency strategies that address these challenges
  • Manages PV physicians in the preparation, analysis and presentation of safety information
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Medical degree required or internationally recognized equivalent.
  • Minimum of 10 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 5 years in a global pharmacovigilance organization. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required.
  • Direct clinical experience with patients following post-graduate training with appropriate grounding and knowledge of general medicine.
  • Minimum of 5 years experience in people management and well-developed skills in teambuilding, motivating and developing people.
  • Demonstrate integrity
  • Relate well to people at all levels
  • Motivate and empower others
  • Work productively in a high pressure environment
    • Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
    • Project Management abilities
    • Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
    • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
    • Attention to details, computer literacy, knowledge of safety database
    • Take initiative and autonomous action
    • Able to lead teleconferences and meetings
    • Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills

PHYSICAL DEMANDS:
Routine demands of an office based work environment.
TRAVEL REQUIREMENTS:
Some travel within Takeda global sites may be required.



we are driven to improve people's lives

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Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx


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