Takeda · 19 hours ago
Associate Director, Study Site Engagement
United States
Full-time
Remote
Lead/Staff, Director/Executive
10+ years expTakeda is a leading global pharmaceutical company, and they are seeking an Associate Director, Study Site Engagement. This role is responsible for establishing effective partnerships between Takeda study teams and clinical research organizations, enhancing engagement with study sites, and supporting trial operations across various therapeutic areas.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
The Associate Director, Study Site Engagement is the local face of Takeda by contributing to an effective partnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA))
The Associate Director, Study Site Engagement establishes communication with regional/country Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies
Associate Director, Study Site Engagement supports study teams with trial operations from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas
The Associate Director, Study Site Engagement, enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel
The Associate Director, Study Site Engagement supports country and site identification, feasibility, site selection, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs
The Associate Director, Study Site Engagement supports Takeda study teams as part of their day-to-day responsibilities and may act as an SSE-Program Lead (SSE-PL) and/or SSE-Study Lead (SSE-SL)
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 and Chinese (simplified); knowledge of Traditional Chinese is an asset
Flexibility
Decision making
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
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
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-25
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2026-01-23
2026-01-22
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