Associate Director, Clinical Operations

Overview

This role is considered Hybrid.

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.

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

• Bachelor's Degree 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.
• Proven track record in resource planning forecasting, and budgeting.
• Previous experience participating in a NDA/BLA is preferred.
• Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs).
• Good organizational skills and ability to deal with competing priorities and prioritize in a meaningful way.
• Comfortable working in a fast-paced environment where speed is paramount.
• Strong communication skills (written, verbal and presentation).
• Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project. Experience with Visio, Veeva systems and/or PleaseReview is a plus.
• Strategic Thinking: General knowledge of all major aspects of drug discovery and development to be an effective problem solver for complex problems.
• Scientific Understanding: Thorough understanding of therapeutic mechanisms of focus and current scientific developments within his/her area of expertise to provide recommendations on both project and disease area levels.
• Role is hybrid-preferred based in Cambridge, MA.

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.