Posted to MedZilla on 3/25/2017


Takeda Pharmaceuticals

US-IL, Manager US Medical Affairs Clinical Research 1700597-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. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. 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:

The objective and purpose of the Manager, US Medical Affairs Research position is as follows:
  • Manage all aspects of the US Medical Affairs Research program including Medical Affairs Company Sponsored Studies (MACS) and Investigator Initiated and Sponsored Research (IISR) studies for multiple therapeutic areas and product programs. Manage TA and product level study budgets and communicate study activities to internal stakeholders.
  • Oversee and manage the activities of USMA research project managers, including the initiation, tracking, completion, and reporting of studies.
  • Responsible for the conduct of MACS and IISR studies within assigned TA in accordance with all applicable internal legal and compliance policies as well as external regional and country specific regulatory guidelines.
  • Serve as the US Medical Affairs Research therapeutic area lead for interfacing with internal stakeholders (e.g. GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc) and external investigators to develop and execute USMA research plans and budgets.

ACCOUNTABILITIES:

  • Assist with the development of the annual USMA research strategy for assigned therapeutic area in collaboration with USMA Therapeutic Area Medical Directors and oversee allocation of the research budget.
  • For IISR Studies:
    • Oversee receipt and processing of study submissions by Medical Affairs staff or external investigators. Review and approve research committee materials including study concepts and protocols, meeting minutes, and investigator communications.
    • Chair and assist regions with the conduct of cross-functional TA research committee meetings used to review, approve, and track studies.
    • Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) from USMA IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.
    • Oversee the conduct fair-market value (FMV) assessments of approved studies for assigned therapeutic area in accordance with Takeda policies and procedures. Manage IISR program budget including forecasting, contracting and invoicing to ensure department goals are met.
  • For MACS Studies:
    • Oversee receipt, processing and meetings required for study concept and protocol submissions. Review and approve research committee materials including study concepts and protocols, meeting minutes, and team communications.
    • Oversee the management of the internal CTMS for studies per Medical Affairs SOPs and processes.
    • Oversee all Clinical Study Manager activities to ensure Company Sponsored studies are conducted in GCP compliant and quality manner in adherence to all company processes and applicable laws.
    • Responsible for management and oversight of cross functional Study Execution Team in order to drive Company Sponsored Studies forward to achieve objectives within target timelines and budget.
    • Manage study contracts and finances including budget forecasting, contract execution & management, change order processes and impact, invoicing and accruals.
    • Assist with SOP development and review to ensure USMA has current processes relevant to current work and future developments.
  • Oversee the tracking and communication of key outputs, performance metrics, and accomplishments related to USMA external research studies within assigned TA.
  • Interface with key internal and external stakeholders (including USMA Therapeutic Area Medical Directors, Scientific Associate Directors, Liaisons, external investigators, etc) to resolve study related issues and support the overall efficient and compliant functioning of the US Medical Affairs Research program within assigned therapeutic area.
  • Manage, direct, coach, and develop individual Project Managers as assigned.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:
  • Bachelor s degree required, preferably in a health sciences related field with 5 years of research related experience and/or pharmaceutical industry experience.
  • Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.
  • Demonstrated understanding of the legal and regulatory guidelines associated with pharmaceutical industry research and external granting functions and the ability to use knowledge to make sound operational decisions.
  • Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to Takeda.
  • Strong understanding of finance principles and their use in managing program budgets.
Desired:
  • Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training
  • Research experience (health sciences related)
  • Masters Degree in a health related field

TRAVEL REQUIREMENTS:

  • Ability to drive to or fly to internal departmental meetings and/or external medical association meetings.
  • Moderate level of domestic and international travel may be required to attend key internal and relevant global meetings.



we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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