Director, Clinical Trial Management

Vertex Inc.•Boston, MA

1d•Remote

About The Position

General Summary: The Director, Clinical Trial Management is responsible for the planning, oversight, and execution of study and program-level deliverables across a range of study phases within one or more therapeutic areas to ensure corporate goals are met. This role often has responsibility for complex therapeutic areas with multiple compounds under simultaneous clinical development. This role will also manage a high performing global team of Clinical Trial Managers in the fast-paced and expanding Global Clinical Operations (GCO) organization, and may also manage individuals at the Associate Director level who also have program-level responsibilities. This position has a strong affiliation with the GCO Leadership Team and other senior stakeholders within Global Medicines and Development Affairs (GMDA).

Requirements

Demonstration of advanced project/program management skills including timeline and budget management, risk assessment and contingency planning.
Proven track record of successfully overseeing staff to execute and deliver clinical trials on time and on budget, ensuring inspection readiness throughout.
Excellent understanding of GCP, CFR and ICH Guidelines.
Effective team leadership in cross-functional study and program teams, with demonstrated strength in team building.
Significant experience with direct line management of employees.
Excellent verbal and written communication skills, organizational skills, problem solving and conflict resolution skills.
Strong interpersonal skills and demonstrated ability to effectively interface successfully with external parties, including key medical personnel at investigational sites, Key Opinion Leaders, vendors and Patient Advocacy groups.
Excellent presentation skills with ability to adapt communication and content appropriately based on the intended audience.
Self-motivated and proactive with ability to work independently in highly time sensitive environment.
Proficiency in Microsoft Office applications including Microsoft Project, Outlook, Excel, Word and PowerPoint.
Bachelor's degree in life sciences discipline or related discipline
Typically requires 12 years of experience executing clinical trials globally across all phases of development and 3 years of supervisory/management experience, or the equivalent combination of education and experience.

Responsibilities

Represents GCO as a key Program Team member, responsible for the development and execution of clinical development plans in conjunction with the Program Teams.
Manages Clinical Trial Managers with responsibility for recruitment, resourcing, training, performance management, employee goal setting and career development. May also manage contract staff.
Develops operational strategy (study scenario planning, operational decision points and risks, initial study timeline, study financials) for assigned program(s).
Accountable for operational delivery of all clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout.
Proactively identifies study and program risks and implements contingency plans, providing regular updates on study status to GCO Leadership Team and senior stakeholders in GMDA.
Participates in vendor identification and oversees Clinical Trial Managers in vendor set up and oversight.
Active involvement in investigator identification and selection, including the expansion to new geographies.
Provides oversight on the development of study documentation, including clinical trial protocols, study plans and clinical study reports.
Participates in cross functional study data review where appropriate.
Develops departmental goals and objectives for Clinical Trial Management.
Tracks key performance indicators and departmental metrics for Clinical Trial Management and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).
Leads cross-functional initiatives
Serves as representative for Clinical Trial Management on vendor-related Joint Operating Committees.