Director, Site Activation

Job Description

General Summary:

The Director, Site Activation will oversee the Study Start-Up portfolio within a dedicated region and across therapeutic areas, managing the Study Start-Up personnel and regional management of Start-Up and acting as a member of the Global Start-Up leadership team. This role takes direction from the SSU Head and in coordination with the global study Start-Up team, will set the strategic direction for Study Start-Up planning in the region and will provide oversight and leadership to drive the Study Start-Up activities associated. Furthermore, the Director, Site Activation will work collaboratively with all business partners to communicate decisions, issues, risks and mitigations and will act as an SME for the regional regulatory landscape to drive accelerated Start-Up timelines.

Key Duties and Responsibilities:

• Leads multiple programs within the assigned region to ensure investigative sites are activated in accordance with the timelines set forth for each study
• Performs proactive risk assessment to anticipate study specific challenges and requirements and communicates in advance to the internal team to plan and mitigate risk
• Analyzes projects through the collection, tracking and trending metrics and KPI assessments and guides internal and external teams to achieve industry leading results for study activation
• Advises on and influences conversations related to study start-up strategy, timelines and activation activities
• Counsels on activation trends and makes strategic recommendations to internal teams to leverage the regional clinical trial environment
• Builds, leads and sustains a team of Start-Up professionals to develop relationships with internal and external stakeholders, resulting in delivery of Start-Up milestones that meet all quality, compliance and time requirements
• Provides mentorship and support to enable team members to deliver key objectives
• Oversees and manages Clinical Research Organization(s) and/or Functional Service Provider(s) for assigned region
• Develops and maintains strong relationships with regulatory authorities, ethics committees as well as patient and trial networks in the region
• Represents Vertex within forums, external meetings and conferences
• Evaluates, analyzes and optimizes internal processes to support activation of investigative sites
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Ability to display a strong leadership presence in a regional department
• Outstanding written and verbal communication across multiple regions and cultures to persuade leaders to take action
• Proven strong business acumen, leadership and interpersonal skills
• Ability to identify and develop key talent
• Excellent skills interacting with internal and external parties
• Proven strategic thinking skills
• Exceptional critical thinking and problem-solving skills
• In-depth understanding of relevant Clinical Research and Study Start-Up processes and industry trends
• Solid working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and significant experience with investigative site Start-Up documents
• Experience leading change management and process improvements / implementations
• Fluency in English and a second language
• Previous personnel management experience required

Education and Experience:

• Bachelor's degree
• Typically requires 10 years of experience in Clinical Development and 3 years of supervisory/management experience or the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com