Associate Director, Study Site Engagement

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

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 regional/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 maintaining 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 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.

EDUCATION & EXPERIENCE:

• 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
• Clinical trials processes
• Clinical trials regulations as per regional/country requirements
• Advanced knowledge and understanding of ICH-GCP
• Healthcare industry knowledge preferred
• Outsourcing/CRO knowledgebase
• Common computer programs and databases (such as MS Office
• Global and cross boundary communication
• Relationship Management & Influencing skills
• Fluent in spoken & written English

Travel:

• Travel frequently in assigned region (required travel may be as high as 50% during busy period.