Takeda · 6 hours ago
Associate Director, Study Site Engagement
Takeda is a global biopharmaceutical company focused on bringing better health and a brighter future to patients. The Associate Director, Study Site Engagement plays a crucial role in fostering effective partnerships between Takeda study teams, study sites, and Clinical Research Organizations, while supporting trial operations and engagement strategies throughout the clinical study lifecycle.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Supports the SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSE/LOC support
Reports any discrepancy on feasibility progress to SSE-PL/SSE-SL
Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team
Attends Pre-Study Visit (PSV) as requested or agreed upon with the SSE-SL
Helps to follow up with country MA, local Clinical Operations team and keep track of country and site selection activities
Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned
Attends and/or supports SIVs
Helps SSE-PL/SSE-SL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Takeda study team
As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO
Supports recruitment strategy and activities when targets are not met (e.g. utilization of PR&R materials, booster visits, phone contacts)
Interacts closely with local CRO team throughout the lifecycle of the study
Helps coordinate and/or attend booster visits or other activities requested by SSE-PL/SSE-SL
Regularly interacts with priority sites in assigned trials
The Associate Director, SSE is expected to comply with internal guidelines and utilize company-provided tools, (i.e., MS Forms, etc.), for applicable tasks and reporting
Participation in following activities may vary depending on assignment by Line Manager:
The Associate Director, Study Site Engagement, may be responsible for resource and talent management of Sr. Managers and/or Managers, SSE (as applicable) across relevant regional/country clusters to achieve site engagement deliverables and GDO objectives
Establishes communication and regular interactions with regional/country Medical Affairs (MA) and provides updates on planned and ongoing global clinical studies, with a focus on country landscaping, upcoming feasibilities, study status and enrollment updates, specific site issues and HCPs contacted in the region/country
The Associate Director of Study Site Engagement plays a key role in shaping the global Site Engagement Strategy for the assigned trial, adapting it as necessary to meet specific requirements of each country
Attends program and study level meetings, as applicable, and provides relevant updates to SSE team members. Attends kick-off meetings, investigator meetings (in region)
The Associate Director, Study Site Engagement, may be responsible for developing and maintaining long-term strategic relationships with selected sites/site networks to improve the site and Takeda experience
The Associate Director of Study Site Engagement may be tasked with developing and executing the SSE strategy for non-study specific activities within their designated Therapeutic Area (TA) or Country
Through participation in conferences or congresses, the Associate Director of Study Site Engagement utilizes these key site-facing events to connect with sites beyond their physical locations. This role involves engaging with new clinical trial investigators or those unfamiliar with Takeda, thereby promoting support for the advancement of our pipeline
Qualification
Required
Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medical/healthcare is preferred but not mandatory
10+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials. The total cumulative work experience of the candidate may also be taken into consideration
Ability to work independently and in teams
Work cross-functional globally
Global and cross boundary communication
Business Acumen
Organization and planning
Time management
Emotional intelligence
Problem solving
Relationship Management & Influencing skills
Fluent in spoken & written English
Flexibility
Decision making
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Recent News
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