Role Summary
Global Medical Evidence - Integrated Evidence Generation Plan Lead responsible for developing strategic integrated evidence generation plans for rare diseases, growth and launch brands. Collaborates with the Global Program Team Evidence Generation sub team and cross-functional partners to anticipate gaps and align strategic and tactical initiatives across therapeutic areas. Provides scientific leadership for peri- and post-approval research programs and real-world evidence strategies, and leads discussions with internal and external audiences. Location: Cambridge, MA - Hybrid.
Responsibilities
- Lead the development of a strategic integrated evidence generation plan across therapeutic areas, proactively anticipating gaps and adjusting tactical plans.
- Contribute to asset strategy through cross-functional collaboration and membership on matrix teams.
- Lead peri- and post-approval interventional and RWE prospective study design within the Global Medical Center of Excellence.
- Provide innovative scientific input into peri- and post-approval research programs and real-world evidence strategies.
- Lead and drive discussions at the Evidence Generation Sub-team to internal and external audiences.
- Support the development of strategies for all study types within Global Medical (e.g., Medical Affairs Sponsored Studies) and develop Areas of Interest for collaborative research and IIRs.
- Identify research gaps, develop aligned strategic and tactical plans, and collaborate with GMA GPT representatives and partners responsible for executing the evidence generation plan.
- Drive, build, and maintain strategic evidence generation plans with input from stakeholders across regions and functions; establish a framework to support evidence generation needs.
- Collaborate with cross-functional teams to define global evidentiary needs of regulators, HCPs, patients, payers, and HTA bodies.
- Map and plan evidence generation activities with key internal stakeholders to develop integrated strategies and plans; share data and best practices across Takeda.
- Prepare and review research protocols, SAPs, and reports reflecting ongoing or completed work.
- Provide strategic leadership and scientific direction on medical evidence activities, including setting standards for utilization of medical data and maximizing patient access to medicines.
- Participate as a strategic and functional expert on cross-functional leadership teams; ensure compliance with policies and SOPs; manage budget and contracts.
Qualifications
- Required: Masterโs degree (preferably PhD) in a health sciences-related field with 10 years of research or pharmaceutical industry experience.
- Strong and effective communication skills.
- Experience with late-stage clinical studies, research collaborations, and RWE; knowledge of HTA/payor needs.
- Proven leadership and project management abilities; capacity to manage multiple complex studies.
- Ability to collaborate and communicate effectively with multicultural stakeholders internal and external to Takeda.
- Broad experience in collaborating with research partners and managing multiple tasks and complex projects.
- Ability to communicate scientific evidence clearly in written and verbal formats; strong presentation skills.
- Networking, communication, and influencing skills; ability to lead cross-functional teams and influence without authority at senior levels.
- Preferred: Experience mentoring others with diverse scientific and non-scientific backgrounds; experience in a large global organization with matrix structure.
Education
- Masterโs degree required (preferably PhD) in a health sciences field with 10 years of relevant research or pharmaceutical industry experience.