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The Sr. Director/Director, Clinical Operations is a member of the Clinical Operations Department. The Clinical Operations department is responsible for the management (planning, implementation, maintenance and close out) of the Clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety. There are approximately 10 employees in the department with some of the activities outsourced to Clinical Research Organizations.

The Sr. Director/Director, Clinical Operations will lead the execution and delivery of all project activities related to a product (project). They will drive tactics and implement to implement department and corporate strategy. The Sr. Director/Director, Clinical Operations aligns activity within the cross functional project team which consists, at a minimum, of representatives from Medical, Clinical Operations and Regulatory Affairs departments.

Projects are conducted according to current uniQure international project / project management standards as required by Corporate and International guidelines and regulations e.g. ICH-GCP, CTD, GMP.

Key result areas (major duties, accountabilities and responsibilities):

The Sr. Director/Director, Clinical Operations owns a clinical project (a compound) from “end to end”. The Sr. Director/Director, Clinical Operations will own implementation of departmental and corporate strategy across multiple clinical trials for the same compound. They will guide and mentor the teams supporting trials within their project and will be make tactical decisions relative to their delivery.

• Strategic and Leadership activities:

  • Coordinates strategy gets stake-holder agreement and executes plans
  • Is accountable for the delivery of the project(s) within the portfolio to achieve agreed timelines, scope, quality and budget.
  • Creates and integrates clinical, regulatory and partnering aspects into overall project plan
  • Manage staffing needs to ensure adequate resources are assigned to achieve project deliverables. Responsible for resource planning and hiring
  • Provides timely and accurate input to clinical development plans including forecasting of timelines, assessment of feasibility for protocol design, estimation of resources, and project level budget
  • Manages, tracks, and troubleshoots a series of related project (e.g. trials, regulatory submissions, manufacturing issues) within a single project or multiple projects
  • Maintain up to date knowledge of relevant therapeutic areas including a broad awareness of Pharmaceutical Industry issues
  • Writes Clinical Trial Protocol(s) and CTP Amendment(s) (or oversees delegate)
  • Plans Investigational Medicinal Product (IMP) manufacturing and distribution
  • Plans and coordinates of activities between expert roles (e.g. Clinical Data Management Expert, Statistical Expert), as required
  • Ensures the writing of CSRs
  • Provides overall project support
  • Review of clinical trial related documents
  • Supports Project Manager(s) and CTM(s) with issue and risk management
  • Supports vendor selection and contracting
  • Acts as an escalation level for decision making related to project and project issues.
  • Ensure effective communication channels exist and are managed across cross functional teams, including third party vendors.
  • Builds strong relationships with individuals and groups to identify opportunities for sharing of best practices and to align activities and process where appropriate.

• Control activities:

  • Monitors compliance with uniQure policies (e.g. through Key Performance Indicators (KPIs), quality plans, audit findings)
  • Monitors & Reports on project and project progress
  • Monitors project start and project closure (e.g. Project Management Plans / End Reports, review and sign off, etc.)
  • Monitors project planning, budget, resources, scope and quality through use of KPIs.
  • Ensures a timely delivery of the contracted activities for selected vendors as well as oversight with regards to deliveries
  • Application of best practices of project & project management e.g. risk management, monitoring of KPIs , change management; priority setting conflict management etc );
  • Ensure that project team members are appropriately informed / trained on project / project-related issues.
  • Provides input to project-related objectives for the project team(s) and supports the project team(s) in planning project budgets, timelines and resources needed to achieve project objectives and milestones

• Project execution activities:

  • Have oversight on all project activities e.g. Investigator Sponsored Trials (ISTs), Clinical trials, PSURs, MAA, variations etc
  • Implements and oversees project level budget, resources and timelines; communicates initial budget and changes to review bodies as appropriate
  • Coordinates the input for Long Range Plans
  • Writes and regularly reviews the project plan
  • Supports the project team(s) in planning to achieve project objectives and milestones
  • Assist in audits and inspections as appropriate Project startup activities
  • Responsible for project “kick-off” for new projects, including confirmation of members of project team
  • Work closely with all team members to apply program and project management processes such as definition, initiation, planning, execution, review and risk management
  • Collaborates effectively with cross-functional teams and external partners
  • Reviews staffing needs and communicates with Head Clinical Operations to ensure adequate resources are assigned to achieve project deliverables
  • Identifies project risks; proactively creates and implements mitigation strategies

Qualifications & Skills:

  • Bachelor’s degree required; advanced degree preferred; medical related degree preferred
  • 10 or more years R & D experience in biotech, pharmaceutical or relevant clinical CRO, including 8+ years in clinical trial management
  • Strong interpersonal and communication skills.
  • Experience in and knowledge of conducting international Clinical Trials.
  • Experience in complex clinical research projects and early drug development very desirable particularly within an orphan/rare disease therapeutic area.
  • A strong proven people manager able to grow and maintain high performing teams
  • • Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
  • Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning.
  • Knowledge of International guidelines and Regulations (e.g. ICH-GCP)
  • Read, write and speak fluent English
  • Excellent written, oral communication and presentation skills
  • Prior experience in the financial and/or Budget and Forecasting management of clinical trials is preferred
  • Diplomatic behavior
  • Proven excellence in cross-functional matrix and/or cross-cultural partnership setting
  • Current knowledge of ICH-GCP, EU CT Directive and FDA regulations. Prior experience in Gene Therapy trials is preferable.
  • Visibility of work requires attention to detail, excellent organizational skills, and discretion with confidential information

Core Competencies:

  • Capability and desire to act as mentor to the trial team
  • Enthusiastic and proactive; ability to fill work gaps as needed
  • Excellent problem-solving capabilities. Solution oriented.
  • Able to cope with ambiguity, has interpersonal savvy and perseverance,
  • Composure under stressful circumstances
  • Conflict Management
  • Managerial Courage
  • Organizational Agility, Strategic Agility
  • Proven ability to Build Effective Teams
More information
This listing is a full-time job

Active since 30-10-2018
Location Lexington
Educational level HBO
Hours 40
Level Manager
Salary Competitive
Job category Science, research & development
Industry / Industries Biotechnology
Region United States

Contact information

Name Jennifer Wagner