Senior Director, Study Start Up

Responsibilities

The Senior Director, Study Start Up is responsible for leading predictable and consistent delivery of study start up across the Clinical Operations portfolio of clinical trials. He/she/they will head the Study Start Up (SSU) team 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 study start up targets/milestone. He/she/they will provide strategic and operational leadership across clinical projects and contribute to defining the overall program strategy as it relates to study start-up.

The Senior Director, Study Start Up is an effective team leader. He/she/they is/are responsible for visioning and delivering the Study Start Up capability, creating data-driven and technology-enabled strategies within SSU, site engagement activities, talent development, providing line management, and supervision of team members in the group. He/she/they is/are responsible for building technical skills within SSU to ensure effective delivery of study start-up. 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, Study Start Up partners closely with Clinical Operations and Global Trial Optimization team members, 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 SSU team to provide start up strategies and key data-driven insights to effectively drive country and site start-up. He/she/they provides data-driven assessments of country and site start up scenarios, country and site start up sequencing strategies, risk mitigation strategies, and start-up data to drive predictable study start-up of global clinical trials. He/she/they creates the infrastructure and team skills to lead and oversee the end to end start up execution in coordination with Regulatory, Clinical Operations, and CRO partners. The Sr. Director, Study Start Up 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, Study Start Up serves as an expert in study start-up practices and is responsible for identifying and implementing appropriate processes, tools and technologies. He/she/they develops and shares best practices within his/her team and across the Clinical Operations organization to deliver consistent application of practices. He/she/they uses country and site intelligence, past performance, and expertise to prevent and remove roadblocks to timely country and site activations. He/she serves as a point of escalation for study teams and CROs for country and site activation issues.

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 Study Start Up (SSU) capability and team.
• Develops and implements strategies to maximize study start up competency and skills related to clinical operations trial delivery with expert specialization in study start up.
• Responsible for shaping the Study Start Up 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.
• Focuses on data-driven estimates, benchmarking assumptions, and robust scenario planning.
• Partners with CRO 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 the early planning of study start-up to ensure proposed CRO 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 and start up.
• Creates the overall start up strategy and process that is flexible, yet systematic across the pipeline
• Oversees end to end start up inclusive of site selection, country submission and approval, EC/IRB submission and approval, site contracts management, and site activation
• Oversees consistent county application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements.
• Partners with CRO and Expertise Areas to capitalize on historic country and site-specific data and documentation (e.g. previously negotiated clauses).
• Partners with CRO and internal stakeholders to ensure effective start-up processes, utilizing appropriate technologies, as required, to deliver best-in-class country and site activation performance.
• Uses country intelligence and expertise to remove roadblocks to timely site activation by calling upon subject matter experts to remediate issues and apply continuous improvement principles to proactively prevent recurrences.
• Point of escalation for SSU/Study Teams/CRO.
• Provides relevant KPI/metrics and local country cycle times to support process improvement and overall operational/business reporting.

• Builds and maintains study start-up and country and site activation best practices.

• 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.

Qualifications

• University Degree in Science or related discipline. A higher degree would be 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, study start-up, or related disciplines.
• Significant (10+ years) line management experience including experience in leading global study start-up
• Must have experience leading/managing external CRO cross functional teams.
• A broad-based experience in clinical development including clinical trial conduct, study start-up and feasibility, and patient retention and recruitment.
• Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.
• Proven track record in department and capability visioning and execution, resource planning forecasting, and budgeting.
• Experience in leading global and/or remote based teams.
• Expert knowledge of global regulatory, ethics board, legal, and site start up requirements and best practices for clinical trials.
• Experience in developing and implementing global study start-up plans and strategies.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• 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 CROs, regulatory authorities, and study teams.
• Experience in mentoring and developing junior team members to enhance their skills and career growth.
• Strong problem-solving skills with the ability to identify and mitigate risks effectively.
• Familiarity with clinical trial management systems (CTMS) and electronic trial master file (eTMF) systems.
• Ability to travel up to 30%.

Requirements

• 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 problemsolving 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.
• Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs).
• Willingness to travel internationally as required. If UK based, quarterly trips to US headquarters.
• Superb communication skills (written, verbal and presentation).
• 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.