Associate Director, Clinical Operations
Overview
Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. Alnylam currently has two commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,300 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work, a Great Place to Work in the U.K. and Switzerland and Science Magazine's #1 Top Employer. Please visit www.alnylam.com for more information.
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.
* Meet departmental and project productivity and quality metrics and provide financial and management accountability to a wide range of audiences.
* Partner directly with or guide staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol and study designs.
* Participate in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review, providing direction to junior staff.
* Effectively discuss and represent study data across the company; collaborate with medical writers and investigators to write, publish and present data.
* Develop tracking tools and oversee project budgets, study timelines, and deliverables.
* Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and day-to-day operational management activities of CROs.
* 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, and budgetary and financial information.
* Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects.
* Identify and report potential program/project issues and resource deficiencies effectively and in a timely manner and implement corrective action.
* Organize logistics and partner with supply operations to manage clinical trial product supply and labeling of study drug.
* Assist in the development of global department standards and successful implementation of process improvements.
* May manage performance, development and growth of junior staff.
* 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.
* 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.
* 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.
* Scientific Understanding: Thorough understanding of therapeutic mechanisms of focus and current scientific developments.
* Clear alignment with Alnylam's Core Values:
o Commitment to People
o Innovation and Discovery
o Sense of Urgency
o Open Culture
o Passion for Excellence
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