Director, Feasibility

 This role is considered Hybrid.

Responsibilities:

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.

Summary of Key Responsibilities:

• 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.
• Partners with CROs and vendors to capitalize on historic study/site performance data, competitor trial performance and industry benchmarks using a variety of analytics and modeling tools to drive baseline study milestones targets/dates (CLOCK).
• Partners with Clinical Operations, Regulatory, and Medical Affairs/local country offices to obtain local insights into country and site selection.
• Provides internal expertise in early planning 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 updates on feasibility insights and process to study and program team stakeholders including escalation of key issues, risks and recommended solutions to address
• Leverages and effectively communicates key feasibility insights to influence and inform protocol development, study timelines, operational plans, country and site selection and help inform recruitment and patient recruitment strategies.
• Brings through key commercial and regulatory strategy plans aligned with the clinical development plan.
• Creates, collates, interrogates data provided from data analytics team, CROs, and other EAs, and actively applies insights resulting in concise recommendations.
• Supports and leads governance meetings where feasibility data and insights are required.
• Maintains continuity connecting and documenting changes from early estimates through baseline (CLOCK) and rebaseline, optimizing operational delivery considering time, cost, quality, and burden.
• Effectively listens to stakeholders to understand problem statements and ascertain data to answer key questions for protocol design and execution.
• Continually improves the overall feasibility strategy and process to be flexible, yet systematic across the pipeline.
• Actively participates and/or leads in the development of the Feasibility CoE department’s vision, standards and successful implementation of process improvements and change.
• Maintains awareness of biopharmaceutical business, operational trends and external organizational developments to help define future strategic direction.
• Drives a patient- and site-first mindset throughout the organization to create more successful, inclusive, and optimized clinical trials.
• Takes on Feasibility process ownership or Subject Matter Expert role, and supports other Feasibility team members by providing advice / consultation for complex or large programs

Qualifications:

• 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
• Extensive knowledge of drug development, a thorough understanding of the processes associated with feasibility, clinical study start-up, and business operations
  • Demonstrated knowledge of clinical research processes and regulatory requirements.
  • Demonstrated ability to manage complex projects and cross-functional processes required
  • Demonstrated platform skills; experience presenting to large non-science populations
• Well-developed strategic planning, analytical operational execution, and problem-solving skills
• Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
• Experience in mentoring and developing junior team members to enhance their skills and career growth.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Familiarity with clinical trial management systems (CTMS) and external data sources.
• Ability to travel up to 30%.

Requirements:

• 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.   

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.