Associate Director, Clinical Operations

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

Qualifications, Skills & Experience

• 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 including 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

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.