Director, Clinical Operations (Clinical Systems, Analytics & Insights)

The Director, Clinical Operations (Clinical Systems, Analytics & Insights) is a clinical research drug development expert with broad accountability for leading the strategic direction and optimizing the delivery of key clinical trial platform support functions that help Clinical Operations scale for the future and achieve its operational excellence goals.  These functions include (but not limited to) clinical systems (TMF, CTMS), technologies and metrics
(data lake/aggregation and reporting layer).  Said thought leader will also be responsible for enhancing our analytics capability to drive insights, process improvements and informing our operational model transformation.   

The individual leads transformative and innovative initiatives that build internal capabilities and create effective and efficient processes that meet high compliance standards; collaborating across Clinical Operations and the broader development organization; serving as a change manager to implement new strategies, systems and practices that support the
organization as we continue to grow.

The individual is an effective clinical operations team leader accountable for talent acquisition, development, management, and evaluation of team members in his/her/their group.  This includes responsibility for the ‘What’ (delivery to performance goals) and the ‘How’ (deliver consistent with Alnylam core values).

The individual is also a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients.

The individual actively participates as a member of the Clinical Operations Leadership Team to drive, evolve and optimize strategy, performance and culture.  He/she provides leadership with key aspects of trial delivery optimization, provide business level leadership, foster best practices, and consult on GCP and operational aspects of clinical trial conduct across the development and operations organizations.  He/she executes on activities that shape and enhance company culture and impact organizational business acumen (e.g., extended leadership engagement, all team meetings) with an outcome to improve culture, enhance retention of team members and reduce unplanned attrition.
 

This position reports to the Vice President of Vendor Management, Business Operations and Systems within Clinical Operations.

Summary of Key Responsibilities:

• Subject matter expert, business and systems owner for TMF, CTMS; accountable for the development, implementation, and oversight of the CTMS and TMF systems, related processes and teams.
  • Oversee TMF and CTMS vendors, contractors, and related budgets.
  • Develop, implement, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement.
  • Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards.
  • Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations.
  • Lead and manage a direct and extended team of TMF and CTMs colleagues and ensure their continuous development.
  • Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS
  • Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections.
• Subject matter expert, business and system owner for internal clinical datalake, aggregation and reporting platform
  • Implement greater predictive analytics and signal detection capability across to support study planning, start-up, enrollment and post enrollment activities.
  • Partner with key internal stakeholders/functions to explore and establish partnerships with external organizations to provision key data for benchmarking (delivery, quality, cost, etc.)
  • Develop and implement a data driven insights program, incorporating internal and external cross functional data to optimize our development model.
  • Develop, implement, report and manage ClinOps leading indicators and KPI/metrics.
  • Produces timely and value-added analysis of leading indicators, KPI/metrics.
  • Produces resource demand forecasting; produces timely and value-added analysis of demand trends across studies/roles.
  • Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals.
  • Lead and manage a direct and extended team of clinical systems colleagues and ensure their continuous development.
• Instill a culture of continuous improvement; acts as a change champion and effectively leads change.
• Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution.
• Travel on assignment, ≤ 25%

Requirements

• University degree (e.g. BA, BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred.
• Strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS, operational data warehouse) preferred.
• Extensive experience with predictive analytics, data governance, AI, Machine learning, clinical trial optimization.
• Proven line and functional manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff.
• Experience in Phase I – III execution of clinical trials in prevalent and rare medical conditions preferred.
• Previous regulatory inspection experience preferred.
• Comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines.
• Solid vendor oversight experience including contracts and budget management preferred.

Skills

• Excellent interpersonal, verbal, and written communication skills, including experience in delivering presentations at conferences, meetings, and training sessions.
• Experience with Microsoft based applications and ability to learn internal computer systems.
• Willingness to work effectively with multiple supervisors in a matrix environment and value the importance of teamwork.
• Continuous improvement mindset with the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment.
• Ability to concisely present significant issues and criticality to senior leaders
• Diplomatically address sensitive issues confidentially and professionally
• Ability to build and maintain relationships with internal (e.g. EAs) and external (e.g. CROs, systems vendors) leaders and their site staff.

• Innovator, willing to initiate and champion changes, introduce new ideas, and creatively problem-solve.

• Provide leadership to teams and projects to aid in successful conclusion.
• Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups.
• Demonstrate good judgment and decision-making experience.
• Work professionally with highly confidential information.
• Work independently and within a team.
• Ability to delegate tasks to vendors and oversee delegated activities.
• Ability to train new and existing less experienced Clinical Operations members.

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.