Join to apply for the Associate Director, Clinical Operations role at Alnylam Pharmaceuticals

Continue with Google Continue with Google

1 week ago Be among the first 25 applicants

Join to apply for the Associate Director, Clinical Operations role at Alnylam Pharmaceuticals

Get AI-powered advice on this job and more exclusive features.

This role is considered Hybrid.

The Associate Director, Clinical Operations is responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning.

The role is hybrid 2x days week office based in Maidenhead, UK.

Key Responsibilities

• Lead and manage cross functional, matrixed team for the integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences
• Partners directly with or guides staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol and study designs and other key study and program/project deliverables
• Participates in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provides direction to junior 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
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
• Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
• Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects
• Identifies and reports potential program/project 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/project
• Assists in the development of global department standards and successful implementation of process improvements and change
• May Manage performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving; highly experienced as a line manager
• May be required to represent Clinical Operations on cross‑functional partner teams
  
  

• Bachelor's Degree (or equivalent) is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
• 8-10 years professional and project management experience in delivering clinical operations of global clinical trials required
• 6+ years managing global clinical studies in a matrixed cross functional environment
• Significant experience with EUCTR
• Cardiovascular/Metabolism clinical trial experience preferred
• Phase 2/3 global trial management experience required
• Experience with direct management of people i ncluding resource planning is preferred
• Comprehensive understanding of ICH-GCP
• Expert time management skillset and ability to work under pressure in an ever-evolving environment
• Strong communicator
• Proficient with all Clinical Operations platforms including CTMS, eTMF, IRT, EDC
• Proactive strategic thinker who is solution orientated and can problem solve by leaning on their extensive experience of drug development
• Scientific understanding for drug mechanism of action and patient care pathways
  
  

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

Referrals increase your chances of interviewing at Alnylam Pharmaceuticals by 2x

Get notified about new Associate Director Clinical Operations jobs in Maidenhead, England, United Kingdom.

Camberley, England, United Kingdom 2 weeks ago

Bracknell, England, United Kingdom 3 weeks ago

Associate Clinical Data Manager - Early Phase Trials

Maidenhead, England, United Kingdom 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.