Global Medical Evidence - Integrated Evidence Generation Plan Lead

Role Summary

Global Medical Evidence - Integrated Evidence Generation Plan Lead

Responsibilities

• Leads the development of a strategic integrated evidence generation plan for rare diseases, growth and launch brands. Partners with the Global Program Team (GPT) Evidence Generation sub team (a multidisciplinary team), to develop/optimize the integrated strategic evidence generation initiatives across therapeutic areas, proactively anticipating any potential gaps and adjusting tactical plans to address these.
• Contributes to the asset strategy through membership on matrix teams and through interactions with cross-functional partners
• Leads the development of peri -and post-approval interventional and RWE prospective study design within the CoE of Global Medical.
• Provides innovative thinking and scientific expertise into peri- and post-approval research programs and real-world evidence strategies.
• Lead and drive discussions at the Evidence Generation Sub-team to relevant internal and external audiences as effectively as possible
• Supports the development of a strategy for all study types within Global Medical, i.e. Medical Affairs Sponsored Studies (MACs). Also, develops Areas of Interest (AOI) for Collaborative research and IIRs.
• Leads strategic discussions for each assigned therapeutic area to identify research gaps and develop aligned strategic and tactical plans to address these gaps. And works closely with GMA GPT representatives and partners responsible for executing evidence generation plan;
• Drives, builds and maintains the strategic evidence generation plans, closely partnering with the Global Medical Lead (GML), Global Patient Access (GPA) and Global Evidence and Outcomes (GEO) with input from multiple stakeholders (regions, Statistical and Quantitative Sciences (SQS), etc);
• Establishes GMA framework (i.e. subteam to asset strategy team) to support evidence generation needs;
• Collaborates with cross-functional team members to define global evidentiary needs of key stakeholders (Regulatory bodies, HCPs, Patients/caregivers, Payers, and HTA bodies) to serve the evolving healthcare environment;
• Supports collaborative strategic planning and mapping of evidence generation activities with key internal stakeholders to develop aligned and integrated generation strategies and plans;
• Enhances collaboration between various groups within Takeda through sharing of data and best practices;
• Prepare and review research protocols from regions and LOCs, statistical analysis plans (SAPs), and reports reflecting ongoing or completed work.
• Provides strategic leadership and scientific direction on medical evidence activities in order to
  • Set standards for utilization of medical data.
  • Maximize patients’ access to our innovative medicines;
• Participates as a strategic and functional expert on other cross-functional leadership teams.
• Compliance with all policies and SOPs.
• Accountable for product annual plan budget and contract/budget management.

Qualifications

• Master’s degree required (preferably PhD), preferably in a health sciences related field with 10 years of research related experience and/or pharmaceutical industry experience.
• Strong and effective communication skills absolutely essential
• Experience with late stage clinical studies, research collaborations and RWE. Knowledge of HTA/payor needs
• Proven track record of strong leadership and excellent project management skills including the ability to manage multiple complex research studies
• Ability to collaborate, communicate and interact thoughtfully, transparently, appropriately and effectively with a variety of multicultural stakeholders both internal and external to Takeda.
• Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is very required
• Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
• Networking, communication and influencing skills. Ability to lead cross-functional teams.
• Ability to influence without authority, particularly individuals at senior levels

Skills

• Advanced level understanding of research and the pharmaceutical industry
• Advanced knowledge of systems

Education

• Master’s degree required (preferably PhD), preferably in a health sciences related field with 10 years of research related experience and/or pharmaceutical industry experience.

Additional Requirements

• Location: Cambridge, MA - Hybrid