Posted to MedZilla on 9/22/2019


Takeda Pharmaceuticals

US-MA, Director, Head of Research, Global Medical Affairs Oncology R0007677-MZ


 
 

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

The Head of Research, Global Medical Affairs Oncology (GMAO) will lead the Research Team and be accountable for execution of the following research programs in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs):

  • Phase IV Takeda Sponsored Research (MACS)
  • Collaborative Research and Investigator Initiated Studies (IISRs)
  • Expanded Access Program (EAP) and Named Patient Program (NPP)

The Head of Research is accountable for external partner relationships (CROs, EAP/NPP vendors), as well as for GMAO research Team leadership and people supervision and budget management.

ACCOUNTABILITIES:

  • Engage with the internal and external oncology community to develop an in-depth understating of the needs of oncology patients to meet those needs
  • Provide leadership and direction to the GMAO Research team by creating and honing its structure, allocating resources appropriately, and motivating the team to successfully execute research activities
  • Oversee the people management of a diverse team including the execution of continuous performance reviews, robust development of associates, and capability and succession planning
  • Provide clinical operations expertise and leadership to execute Takeda sponsored research (MACS), Collaborative Research and Investigator Initiated and Sponsored Research studies (IISRs)
  • Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and provide supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to, and participation in, governance committees when warranted; accountable for operational risk management strategy in collaboration with Strategic Partners
  • Direct the EAPs/NPPs across all products within the Takeda Oncology Business Unit portfolio based on product life cycle considerations, in collaboration with Global Medical Strategy Team Oncology (GMSTO), Global Product Teams (GPTs), Global Brand Teams (GBTs), and OBU leadership
  • Provide clinical operation input into Asset Strategies and Evidence Data Generation Plans and Clinical Development Program for marketed oncology products and products in development
  • Plan budgets and external spend related to program execution. Work closely with GMSTO, GMAO Project management group, and finance to ensure budgets, enrollment, and gaiting are accurate; ensure communication of program status, cost and issues to inform timely decision-making by senior management
  • Represent GMAO-Research Team as a permanent member of the GMAO Leadership Team
  • Establish relationships with key opinion leaders and researchers involved in Takeda Sponsored Research, Collaborative Research and IISRs
  • Build long term cross functional relationships with global functions, GDT, CST, GMSTO and Local Operating Country (LOC)

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • Demonstrated focus on patients interest
  • Bachelor s Degree or international equivalent (life sciences preferred) required and 12+ years industry experience or advanced degree and 10+ years industry experience.
  • Minimum of 5+ years of people management experience
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to ICH GCP, US CFR and EU CTD. Awareness of local country requirements is also required
  • Experience must include early phase experience or Phase 2 and 3 studies and global/international programs. Experience in more than one therapeutic area, including oncology is advantageous
  • Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals.
  • Budgetary and supervisory experience
  • Requires experience and success in working in a matrix, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results
  • Ability to work effectively in a fast paced, rapidly changing technology environment
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead teams
  • Excellent written and oral communication skills
  • Advanced PC skills, including MS Project, Word, Excel, Power Point, Visio and SharePoint

TRAVEL REQUIREMENTS:

Requires up to 25% travel (including overnight and international travel) to other Takeda sites, meet with strategic partners, represent GMAO at industry conferences, and for other purposes

Empowering Our People to Shine

Learn more at www.takedajobs.com

No Phone Calls or Recruiters Please

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.