Associate Director; Standards, Process and Training Lead
Overview
Alnylam is the world’s leading RNA interference (RNAi) company.
Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.
Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 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 six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine’s Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.
The Clinical Operations Standards, Process and Training Lead serves as an operational excellence Subject Matter Expert (SME) on end-to-end study management activities and the quality execution of clinical trials. The role coordinates and delivers on the development, implementation, and maintenance of clinical operations processes, Standard Operating Procedures (SOPs) and learning curriculum to ensure standards are met across Clinical Operations related to Good Clinical Practice (GCP), compliance with global and local regulations, internal SOPs and metrics. The role partners within Clinical Operations to drive the consistent application of standards of excellence in clinical trial execution by promoting a culture of sustained compliance, continuous improvement and proactive end-to-end inspection readiness. In addition, the role participates in and may lead initiatives aimed at innovation, quality, optimization, continuous process improvement and efficiency that align with Clinical Operations and Clinical Development strategy and goals.
Summary of Key Responsibilities
-
- Responsible for driving and managing initial and ongoing role based curricula and study specific training across Clinical Operations with cross-functional collaboration and support for other expertise areas with Clinical Development.
- Responsible for driving and managing processes and SOP development / periodic review for Clinical Operations with cross-functional collaboration and support for other expertise areas within Clinical Development
- Responsible for working within Clinical Operations and cross functionally to drive operational excellence (inspection readiness), mitigate risk, manage CAPAs
- Additional support for Clinical Operations may include:
- Support Compliance and Patient Privacy (GDPR) activities
- May have line manager responsibilities
- May lead and/or participate in working groups, initiatives that drive the healthy conduct of clinical trials and support Clinical Operations as we grow and scale for the future
Qualifications
- Minimum of Bachelor’s Degree from an accredited institution is required (preferably in a clinical or scientific area)
- At least 8+ years of relevant biopharmaceutical experience (sponsor or CRO company) with track record of success in global clinical operations or related discipline including:
- Extensive experience in global clinical trial study/site management
- Evidence of thorough understanding of the processes required to operationally execute clinical trials to a high standard of excellence
- Experience in activities related to process improvement; SOP development and review, role based curriculum management; study specific training management
- Experience supporting response strategy for critical to quality events mitigations, audits and regulatory inspections using established risk management techniques (e.g. root cause analysis, CAPA)
- Solid knowledge of GCP, global regulatory and compliance requirements for clinical trials
- Demonstrated ability to direct, lead, coach, motivate and manage high performing team members in a fast paced, growing company
- Focused on delivery of short and long term goals by connecting day to day operations with higher level internal strategies and external clinical trial landscape
- Responds to change with agility, resilience, innovation and optimism, seeks solutions based on creative problem solving, lessons learned and well reasoned risk taking
- Detail oriented & possesses technical expertise
- Excellent communication (written, verbal, and presentation) and analytical skills
-
- Able to accommodate limited travel (may include international travel) according to business need
- Clear alignment with Alnylam’s Core Values:
- Commitment to People
- Innovation and Discovery
- Sense of Urgency
- Open Culture
- Passion for Excellence
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
