Director, Feasibility

The Director, Feasibility Center of Excellence (CoE) is responsible for leading predictable and competitive delivery of indication, program, study, country, and site feasibility across the Clinical Operations portfolio of clinical trials. He/she/they will partner with key leaders/stakeholders to determine appropriate strategies inclusive of protocol optimization, country and site selection, and enrollment forecasting. He/she/they will provide strategic and operational leadership across the enterprise to contribute to furthering business success while ensuring patients and participants are at the center of decision making. The Director, Feasibility CoE is an effective matrix leader and is skilled in deriving data-driven and technology-enabled insights, enhancing data analytics, developing operational strategies, incorporating site engagement activities, forming an innovative culture, and educating and coaching colleagues and team members. He/she/they is/are critical to broadening data culture and literacy across the Clinical Development organization to ensure strategic planning and effective delivery of Alnylam's portfolio of studies. He/she/they is/are a key leader within Global Trial Optimization (GTO) and supports and influences the direction of the GTO organization. The Director, Feasibility CoE leads and facilitates timely and thorough global (end to end) program/indication, study, country, and site feasibility and is/are the primary contact with study team stakeholders across multiple therapeutic and disease area trials. The role may oversee larger, and/or more complex projects and provide project oversight and direction to other Global Trial Optimization team members. He/she/they consistently delivers high quality insights and application of feasibility practices. He/she/they uses and develops epidemiology, market research, competitive intelligence, past performance, country and site intelligence, and expertise to effectively develop strategies and drive improved decision making for successful trial enrollment outcomes. The Director, Feasibility CoE partners closely with Clinical Operations and Global Trial Optimization team members, Clinical Research, Program and Project Management, Epidemiology, CRO partners, Regulatory, and other key Expertise Areas to ensure predictable planning and delivery of study start up milestones. He/she/they contributes to the framework, education, and tools for the Feasibility CoE to provide intelligent operational strategies and key data-driven insights to effectively drive portfolio and program operational strategies, feasible study designs, predictive enrollment, and country and site selection. 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. He/she/they leads and oversees protocol optimization and protocol success in coordination with Portfolio and Program Management, Clinical Research, Epidemiology, Medical Writing, Clinical Operations, and CRO partners. Site relationships and engagement are a key focus of this role. Ensures consistent and quality feasibility outputs (data analytics of historical / current clinical trials, epidemiology, standard of care, local country input, etc.) that support global operational planning for clinical trials. Ensures on-time and high-quality delivery of feasibility work and deliverables within the EA-aligned projects, from program concept through site selection and routinely to monitor enrollment and rescue studies as needed. Provides internal expertise in early planning to ensure proposed timelines and committed milestones are accurate and achievable. Provides updates on feasibility insights and process to study and program team stakeholders including escalation of key issues, risks and recommended solutions to address Supports and leads governance meetings where feasibility data and insights are required. University Degree in Science or related discipline. A higher degree is desirable. Significant (10+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies and program strategy and track record of success in global clinical operations, feasibility, or related disciplines. Advanced skills to leverage, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning Advanced skills to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team Broad-based experience in clinical research, data analytics, and data evaluation Broad experience of managing multinational clinical trials Advanced verbal and written communication skills Experience in mentoring and developing junior team members to enhance their skills and career growth. Ability to travel up to 30%. Must be self-motivated and able to work independently and successfully. Able to prioritize effectively, lead and influence, with good problem‑solving and planning abilities to enable teams succeed in study start, execution and completion in a timely fashion. 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 and team leadership challenges. Strong problem-solving skills with the ability to identify and mitigate risks effectively. Willingness to travel internationally as required. If UK based, quarterly trips to US headquarters. Ideally a combined mix of large company best practices and small company adaptability and experience. 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.