Senior Director, Feasibility

 This role is considered Hybrid.

Responsibilities:

The Senior 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 head the Feasibility Center of Excellence (CoE) while partnering with other Clinical Operations and Expertise Area leaders.  He/she/they must be able to collaborate, influence, and lead discussions with key leaders/stakeholders to determine appropriate indication, program, and study strategies inclusive of protocol optimization and 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 Senior Director, Feasibility CoE is an effective team leader. He/she/they is/are responsible for visioning and delivering the Feasibility CoE capability which is a critical part of Alnylam’s Development success strategy. This includes creating data-driven and technology-enabled solutions, algorithms, and strategies, site engagement activities, talent development, creating an innovative culture, and line management of team members within the group.  He/she/they is/are responsible for building technical skills within the Feasibility CoE and 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 Clinical Operations and supports and influences the direction of the Clinical Operations group.

The Senior 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 creates 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 creates the infrastructure and team skills to lead and oversee protocol optimization and protocol success in coordination with Portfolio and Program Management, Clinical Research, Epidemiology, Medical Writing, Clinical Operations, and CRO partners. The Sr. Director, Feasibility CoE is responsible for providing KPI/metrics to achieve acceleration for priority programs. Site relationships and engagement are a key focus of this role.

The Senior Director, Feasibility CoE serves as an expert in successful study and program strategies and is responsible for identifying and implementing appropriate processes, tools and technologies. He/she/they develops and shares best practices within his/her/their team and across the Clinical Operations organization to deliver consistent application of 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. He/she serves as a point of escalation for study teams and CROs for protocol execution, country and site selection, and study enrollment.

Summary of Key Responsibilities:

• Active participation as a Clinical Operations Leader in driving strategy and team execution.
• Responsible for the guidance of clinical staff, including hiring, performance management and ongoing coaching.  If UK based, participates as member of UK office leadership team under UK General Manager (GM) supporting the development and continue growth of the UK team whilst also ensuring alignment with UK HQ counterparts. 
• Defines, creates, and delivers a high-caliber Feasibility capability and Center of Excellence.
• Develops and implements strategies to maximize study start up competency and skills related to clinical operations trial delivery with expert specialization in feasibility assessments and execution strategies.
• Responsible for shaping the Feasibility CoE and Global Trial Optimization team culture including the retention and engagement of team members.
• Leads teams towards departmental and project productivity, quality metrics, and provides financial and management accountability.
• Manages the recruitment and performance of junior staff to support and guide them to improved strategic drug development operational efficiency, effectiveness at prioritization, and problem identification and solving.
• Works independently and serves as point of contact for leadership including resolution or escalation of issues as appropriate.
• Ensures integration of feasibility inputs (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.
• Ensures consistent standards are applied for the feasibility process across the portfolio.
• Leads and facilitates specific study-level feasibility activities as required.
• Focuses on data-driven estimates, benchmarking assumptions, and robust scenario planning.
• 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 support the Clinical Operations lock of baseline study milestones targets/dates.
• Provides internal expertise in early planning to ensure proposed timelines and committed milestones are accurate and achievable.
• Partners with Clinical Operations, Regulatory, and Medical Affairs/local country offices to obtain local insights into country and site selection
• Creates the overall feasibility strategy and process that is flexible, yet systematic across the pipeline, inclusive of continuous improvement
• Provides relevant KPI/metrics and intelligence to support process improvement and overall operational/business reporting.
• Actively participates and/or leads in the development of the Clinical Operation department’s vision, standards and successful implementation of process improvements and change.
• Instills a culture of continuous improvement; acts as a change champion and effectively leads change
• Maintain awareness of biopharmaceutical business, operational trends and external organizational developments to help define future strategic direction.
• Establish and drive a patient and site-first mindset throughout the organization to create more successful, diverse, and optimized clinical trial protocols.

Qualifications:

• University Degree in Science or related discipline.  A higher degree is desirable.
• Significant (15+ 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.
• Significant (10+ years) line management experience including experience in leading strategic and data-generating teams
• Knowledge of Drug development.
• Exceptional strategic planning, observation, analytical operational execution and problem-solving skills.
• Must have experience leading/managing external CRO cross functional teams.
• A broad-based experience in clinical development including clinical trial conduct, vendor management, feasibility strategy, portfolio oversight, and patient and site focused efforts.
• Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.
• Experience in leading global and/or remote based teams.
• Experience in mentoring and developing junior team members to enhance their skills and career growth.
• Experience in developing and implementing feasibility and/or strategic study plans.
• 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:

• Proven track record in department and capability visioning and execution, resource planning forecasting, and budgeting.
• Must be self-motivated and able to work independently and successfully.
• Must be able to successfully manage remote base team members as needed and as part of an international development team reporting into our USA based headquarters.
• 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.
• 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.
• Highly developed interpersonal skills including effective verbal and written and communication / presentation skills in English and demonstrated business awareness
• Develop analytical infrastructure and deliverables with key stakeholders inclusive of Clinical Portfolio Services, IT, and vendors.
• Experience in thoughtful and effective vendor selection and vendor management.
• Critical reasoning skills including the identification and resolution of complex problems and team leadership challenges.
• Demonstrated ability in proactive management of operational risks.
• Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict.
• 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.