Director, Site Activation
Director, Site Activation
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Job Description
Job Description
General Summary:
The Director Site Activation will oversee the Study StartUp portfolio within a dedicated region and across therapeutic areas managing the Study StartUp personnel and regional management of StartUp and acting as a member of the Global StartUp leadership team. This role takes direction from the SSU Head and in coordination with the global study StartUp team will set the strategic direction for Study StartUp planning in the region and will provide oversight and leadership to drive the Study StartUp 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 StartUp 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 startup 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 StartUp professionals to develop relationships with internal and external stakeholders resulting in delivery of StartUp 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 problemsolving skills
- Indepth understanding of relevant Clinical Research and Study StartUp processes and industry trends
- Solid working knowledge of ICH FDA IRB/IEC and other applicable regulations/guidelines and significant experience with investigative site StartUp documents
- Experience leading change management and process improvements / implementations
- Fluency in English and a second language
- Previous personnel management experience required
Education and Experience:
- Bachelors 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:
$0 $0Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other jobrelated factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive marketleading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a weeklong company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
RemoteEligibleFlex Eligibility Status:
In this RemoteEligible role you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion youre always welcome onsite; or select
2. Hybrid: work remotely up to two days per week; or select
3. OnSite: work five days per week onsite with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify 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
Required Experience:
Director
Employment Type
Full-Time
