Manager, Feasibility Analytics

Overview

The Manager, Feasibility Analytics is responsible for developing thorough methods of data analysis for clinical trial feasibility insights, specific to indication, program, study, enrollment forecasting, country, and site feasibility across the Clinical Operations portfolio of clinical trials. He/she/they will partner within key stakeholders across the Feasibility Center of Excellence (CoE) to deliver feasibility analytics outputs used to derive optimized operational strategies. He/she/they will provide impactful insights while ensuring patients and participants are at the center of decision making.

The Manager, Feasibility Analytics is an intelligent and effective data-driven leader focused on the acquisition of data, data engineering, algorithm development, automation, and technology solutions to improve clinical trial decision making. The role is responsible for creating the analytics infrastructure for the future and broadening data culture and literacy across the Clinical Development organization to ensure effective delivery of Alnylam's portfolio of studies.

The Manager, Feasibility Analytics works cross functionally with Clinical Portfolio Systems (CPS) and Information Technology (IT) to ensure timely and thorough global (end to end) feasibility outputs that are then utilized by the Feasibility Strategists to apply and influence key trial and program stakeholders. Technologies and data outputs owned by the Feasibility CoE are likely to be utilized across Expertise Areas (EAs) in addition to Clinical Operations (ClinOps). He/she/they consistently delivers high quality outputs and service to fulfill the most impactful suite of feasibility deliverables. He/she/they derives and develops epidemiology, market research, competitive intelligence, past performance, country and site intelligence, expertise, and innovative data and AI methodologies to ultimately drive improved decision making for successful trial enrollment outcomes.

The Manager, Feasibility Analytics is responsible for ensuring precise, predictive, and applicable data and insights packages working closely with the Feasibility Strategists. He/she/they provides data-driven assessments of protocol do-ability, patient voice, site and patient burden, study, country and site enrollment scenarios, country and site selection, and risk mitigation strategies to drive predictable and accelerated study execution of global clinical trials. This role works closely with other analytics colleagues and functions globally, both internal and external to Alnylam.

Summary of Key Responsibilities

• Creates and delivers consistent feasibility data analytics packages; inclusive of, but not limited to, historical / current clinical trials, epidemiology, standard of care, enrollment rates, start up timelines, enrollment forecasts, patient and site burden scores, site lists, site performance prediction, etc.
• Ensures on-time and high-quality of deliverables, specific to each stakeholder's perspectives and needs.
• Routinely monitors enrollment and start up to indicate if clinical trials are performing to plan and then signaling when indicator thresholds are surpassed.
• Partners with stakeholders, CROs, and vendors to capitalize on historic study/site performance data, competitor trial performance, industry benchmarks, epidemiology, etc. using a variety of analytics and modeling tools to drive baseline study milestones targets/dates (CLOCK).
• Provides internal benchmarking and early forecasting to ensure proposed timelines and committed milestones are accurate and achievable.
• Drives improved KPI/metrics and intelligence to support process improvement and overall operational/business reporting.
• Provides improvements to feasibility data and analytics to improve the data infrastructure and usability of data to optimize clinical trials.
• In conjunction with Feasibility Strategists, derives impactful insights from data analyses.
• Optimizes operational delivery considering time, cost, quality, and burden and supports the data and outputs needed to baseline (CLOCK) the study assumptions.
• Effectively listens to stakeholders to understand problem statements and ascertain data to answer key questions for trial optimization.
• Continually improves the overall feasibility strategy and process to be flexible, yet systematic across the pipeline.
• Drives a patient- and site-first mindset throughout the organization to create more successful, inclusive, and optimized clinical trials.

Qualifications

• University Degree in Science, Computer Science, Informatics, or related discipline. A higher degree is desirable.
• Intermediate (2+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies
• Intermediate analytics and data storytelling skills
• Intermediate data engineering skills
• Proven ability to automate data processes and analytics
• Proven skills in dashboard creation
• Proven skills in innovation and scaling technologies
• Proven ability to lead within a matrixed team
• Experience in clinical research, data analytics, and data evaluation
• Experience with global data sets
• Intermediate verbal and written communication skills
• Strong problem-solving skills
• Well developed interpersonal skills, including ability to persuade, negotiate, and moderate conflict
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Familiarity with clinical trial management systems (CTMS) and data flows of external data sources.
• Ability to travel up to 10%.

Requirements

• Must be self-motivated and able to work independently and successfully.
• Able to prioritize effectively with good problemsolving and planning abilities
• Strong organizational skills and ability to deal with competing priorities.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels, including ability to persuade, negotiate, and moderate conflict.
• Ability to analyze complex data and provide actionable insights to drive decision-making.
• Proven ability to build and maintain strong relationships with key stakeholders, including Clinical Research, Regulatory, Epidemiology, Portfolio and Program Management, Commercial, Medical Affairs, Study Start Up, CROs, Study Management, and other Clinical Operations functions.
• Critical reasoning skills including the identification and resolution of complex problems
• Willingness and proven ability to work flexibly stepping outside of immediate role responsibilities and wear 'multiple-hats' where needed.
• Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
• Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.