Associate Director, Clinical Operations

Associate Director, Clinical Operations

Alnylam Pharmaceuticals

Maidenhead, United Kingdom

Responsibilities

The Associate Director, Clinical Operations oversees the details of complex clinical projects and is responsible for the overall clinical operations plan for the program. He/she also contributes significantly to defining the overall clinical program strategy. He/she provides program strategic direction and oversight of clinical research activities within the program, including study design, protocol development, study placement, data collection systems, and final reports throughout all phases of clinical development. He/she must be able to collaborate and lead discussions with key Expertise Area leaders to determine program priorities and execution strategies.

The Associate Director, Clinical Operations is an effective team leader who is able to guide/direct fewer senior staff to achieve desired results. He/she is responsible for talent development and provides line management and supervision of team members in his/her group. As a senior staff member, he/she may collaborate with the Clinical Operations Leadership Team to formulate standards, processes and best practices to be implemented across Clinical Operations.

Summary of Key Responsibilities

  • Provides oversight of all study conduct in the program and ensures staff training;
  • Partners directly with or guides staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol, ICF, IB, study designs and other key study and program deliverables;
  • Participates in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provides direction to less senior staff to manage the process, as necessary;
  • Effectively discusses and represents study data across the company; collaborates with medical writers and investigators to write, publish and present data;
  • Develops tracking tools and oversees project budgets, study timelines, and deliverables;
  • Participates in development of Clinical Operations Plans, Clinical Research Organization (CRO) and vendor outsourcing strategy, and key performance indicators (KPIs) with CRO and reviews KPIs during projects;
  • Partners with Quality Assurance to ensure proper escalation, follow-up and closeout of any quality issues, as well as ensuring the program is inspection ready;
  • Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects within a program;
  • Identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action;
  • Organizes logistics and partners with supply operations to manage clinical trial product supply and labeling of study drug as required by the clinical program;
  • Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences;
  • If UK based, attend, in conjunction with Director/Senior Director of Clinical Operations, UK office leadership team under UK General Manager (GM) supporting the development and continued growth of the UK team;
  • Assists in the development of global department standards and successful implementation of process improvements and change;
  • Manages performance, development and growth of less senior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving; experienced as a line manager;
  • Support the Leadership Team and attend meetings, when appropriate; may be required to represent Clinical Operations on cross-functional partner teams.

Qualifications

  • University Degree in Science or related discipline. A higher degree would be desirable;
  • 8+ years previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies;
  • 4+ years managing clinical studies and direct reports;
  • Must have experience leading/managing external CRO cross functional teams;
  • Experience in the clinical drug development process within clinical program planning, startup including budget and resource planning through final study report;
  • Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs).

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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