Manager, Clinical Operations
Posted on: November 22, 2022
Overview Alnylam (Nasdaq: ALNY) is delivering on a bold vision
to turn scientific possibility into reality, with a robust RNA
interference (RNAi) therapeutics platform. As the pioneer in RNAi
and the leading RNAi therapeutics company, we have always been
uncompromisingly dedicated to translating the breakthrough science
into transformational medicines to help as many people as possible.
Long focused on rare and genetic diseases, our scientific advances
are now allowing us to bring the power of RNAi therapeutics to more
prevalent diseases and as a result, we are beginning to recognize
the full potential of this new class of medicines. Alnylam is
committed to its journey to become a top 5 independent, global
biopharma company. We are already admired and recognized for our
dedication to patients, company culture that empowers people to do
their best work, track record of scientific innovation, social
responsibility, and commercial excellence. Founded in 2002, and
headquartered in Cambridge, Mass., Alnylam has over 1,650 employees
at work across the globe. We are seeking smart, passionate, "change
the world" kind of people who are ready to say, "challenge
accepted" to our mission. Thanks to the commitment of every
employee globally, Alnylam is proud to have been recognized as one
of Fast Company's 2021 Best Workplaces for Innovators, a Science
Magazine Top Employer three years in a row (2019-2021), a Boston
Globe Top Places to Work seven years in a row (2015-2021), a Great
Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain,
Netherlands, Italy, France and Switzerland, Seramount's 100 Best
Companies (formerly Working Mother 100 Best Companies) and Best
Companies for Dads, Bloomberg's Gender Equality Index two years in
a row (2021-2022), among others. At Alnylam, we are committed to
fostering a diverse, equitable and inclusive work environment,
culture, and workforce, and we support several Employee Resource
Networks.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. Summary
of Key Responsibilities
- Lead and manage integration of all project team activities,
leveraging internal and development partner resources, expertise
and knowledge, along with optimizing CRO resources, expertise and
- Provide strategic input and execution of clinical trials from
protocol design to the final clinical study report for specified
- Provide leadership and input into global subject/patient
- Effectively communicate and interact with Key Opinion
- 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
- Participate in Case Report Form design, user acceptance testing
in partnership with data management
- Generate country specific Informed Consent Form(s).
- Lead the development of contingency/risk management plans for
projects and assist Director/Senior Director of Clinical Operations
in the preparation and execution of sound development
- Provide support to clinical trial managers within and/or across
- Budgets, timelines, and forecasts preparation for clinical
- Interface with Finance, Program Management, Accounting, Supply
Operations, Quality Assurance, Clinical Research, Commercial,
Regulatory, Medical Affairs; which may include lading sub-teams
and/or acting as a liaison between groups.
- Provide a variance analysis of budget to actual and notifies
finance of projected cost over/under expenditure.
- Ability to travel (no more than annual average of 20%).
- Bachelor's Degree is required. An advanced degree in a
scientific and/or business/finance discipline is preferred.
- 6 years of clinical research experience gained with a CRO or
Pharmaceutical Company working on later stage (Phase 2-4)
multinational clinical studies. Experience in rare diseases and/or
difficult to recruit patient populations preferred.
- 2-4 years clinical project management experience with global
- Strong regulatory knowledge, including Good Clinical Practices
- Exceptional organizational skills and ability to deal with
competing priorities, also strong reasoning and problem-solving
- Excellent communication (written and verbal) and presentation
skills along with leadership qualities.
- Knowledge of global clinical trial management in fast paced CRO
outsourced environment. Ability to assemble a plan and execute on
- Apply project management best practices to programs. Experience
in novel clinical drug development.
- Experience with protocol, ICF, CRF, CSR development and
- Strong organizational skills and ability to deal with competing
- Proficient with MS Office Suite (Excel, Word and PowerPoint)
and MS Project .
- If employed in the U.S., being fully vaccinated against
COVID-19 as defined by the Centers for Disease Control and
Prevention (CDC) is required Alnylam Pharmaceuticals is an EEO
employer committed to an exciting, diverse, and enriching work
Keywords: Alnylam, Cambridge , Manager, Clinical Operations, Executive , Cambridge, Massachusetts
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