Associate Director, Study Site Engagement

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Job Description

OBJECTIVES/PURPOSE:

• 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 Organi zation (CRO) (i.e., the Clinical Research Associate (CRA)).
• The Associate Director, Study Site En gagement establishes communication with regional/country Medical Affairs (MA), provides up dates on study/site status, and establishes site engagement study specific strategies.
• Associate Director, Study Site Engagement supports study teams with trial operations from Feasi bility 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 recruit ment 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).

ACCOUNTABILITIES:

Study Specific Engagement activities: Early engagement - Country and site feasibility

• 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.

Study startup phase - Post site selection to site initiation

• 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.

Enrollment and study conduct phase

• 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.

Training

• Applicable local regulations
• SOP trainings (Takeda and CRO, as applicable)
• TA/Study specific training

The Associate Director, SSE is expected to comply with internal guidelines and utilize company-pro vided tools, (i.e., MS Forms, etc.), for applicable tasks and reporting.

• Non-Study Specific Engagement activities
• Participation in following activities may vary depending on assignment by Line Manager

People Management:

• 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 re gional/country clusters to achieve site engagement deliverables and GDO objectives.

Cross-functional role:

• 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.

SSE Program Lead and/or SSE Study Lead for assigned programs:

• 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)

Development of Strategic Site Relationships:

• The Associate Director, Study Site Engagement, may be responsible for developing and maintain ing long-term strategic relationships with selected sites/site networks to improve the site and Takeda experience.

Conferences, Congresses, Other Site Facing Events:

• 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 Engage mentutilizes 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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education:

• Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medi cal/healthcare is preferred but not mandatory.

Experience:

• 10+ years of 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.

Essential qualifications:

• 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

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