Director, Study Start Up

Alnylam Pharmaceuticals

1d

About The Position

Alnylam Pharmaceuticals is seeking a Director, Study Start-up to join our dynamic and growing team.
The Director, Study Start-Up (SSU) provides strategic, operational and people leadership across the study start-up portfolio, with accountability for performance, scalability, and continuous improvement of the SSU function. This role sets standards, drives portfolio-level decision-making, and partners at the enterprise level to enable predictable, high-quality start-up outcomes across therapeutic areas and regions.
The Director, Study Start-up is passionate about driving Study Start-up to deliver results while implementing SSU strategy and process standards.

Requirements

• Bachelor’s degree required; degree in Life Sciences, Healthcare, or a scientific discipline preferred.
• 10+ years of experience in global clinical trial operations and/or study start-up, including complex, multi-regional clinical trials.
• 7+ years of people leadership experience, including leading managers and/or senior-level individual contributors.
• Demonstrated success providing strategic oversight of end-to-end study start-up activities, from feasibility through site activation.
• Proven experience leading complex, cross-functional study start-up initiatives with strong project management discipline, including planning, sequencing, risk management, and delivery against timelines.
• Experience driving early planning, risk identification, and issue resolution to deliver predictable study timelines.
• Experience leading development and implementation of SOPs, work instructions, tools, and standardized processes in a regulated environment.
• Strong experience overseeing CRO partners and vendors, including performance management, issue escalation, and accountability against contracted deliverables and KPIs.
• Demonstrated ability to operate effectively in a matrixed, global organization with multiple stakeholders.
• Experience supporting inspections and ensuring compliance with global regulatory requirements.
• Deep understanding of global study start-up processes, including feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation.
• Advanced working knowledge of ICH-GCP and the global regulatory environment.
• Strong project management skills, including development and management of integrated plans, dependency mapping, risk mitigation, and issue resolution across cross-functional teams.
• Proven vendor management skills, including CRO oversight, performance monitoring, governance participation, and driving corrective actions when required.
• Strong leadership and people management skills, including talent development, performance management, and succession planning.
• Proven ability to influence and align cross-functional stakeholders and drive accountability without direct authority.
• Strong analytical and critical-thinking skills, with the ability to interpret data, identify trends, and make sound, data-driven decisions.
• Demonstrated experience using metrics and KPIs to monitor performance, forecast outcomes, and drive continuous improvement.
• Excellent written and verbal communication skills, with the ability to present clear, concise, and persuasive information to senior leadership.
• Strong problem-solving skills with the ability to manage complexity and competing priorities in a fast-paced environment.
• Experience with clinical trial systems and tools (e.g., CTMS, eTMF, IRT, eCOA).
• High level of business acumen, including understanding of cost drivers, resource planning, and operational trade-offs

Nice To Haves

• Advanced degree (e.g., Master’s, MBA, MPH) preferred.

Responsibilities

• Provide oversight of end-to-end study start-up activities, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation.
• Ensure early planning, risk identification, and timely decision-making to support predictable study start-up timelines.
• Serve as the escalation point for study start-up issues, ensuring timely resolution and minimal impact to delivery.
• Lead resourcing, hiring, performance management, and talent development for SSU Leads and/or Managers.
• Establish clear expectations, accountability, and development plans aligned with Alnylam leadership behaviors.
• Lead development, implementation, and training of SSU SOPs, work instructions, job aids, tools, and templates in partnership with the Head of Study Start-Up.
• Drive standardization and consistent execution of study start-up processes across therapeutic areas and regions.
• Lead continuous improvement initiatives focused on reducing cycle time, cost, and operational burden.
• Monitor, analyze, and report SSU performance metrics and KPIs (e.g., site activation timelines, readiness-to-enroll).
• Leverage data-driven insights to drive accountability, forecast performance, and inform portfolio-level decision-making.
• Ensure maintenance and effective use of country and site intelligence to support study start-up strategy and planning.
• Partner with the Feasibility Center of Excellence, Clinical Operations, Clinical Development, Regulatory, Legal, Finance, and CROs to facilitate cross-functional alignment and execution.
• Represent SSU in governance forums, providing clear, data-driven updates, risks, and recommendations.
• Provide oversight and performance management of CRO partners related to study start-up deliverables.
• Ensure study start-up activities comply with ICH-GCP, global regulatory requirements, and internal policies and procedures.
• Support inspection readiness and quality initiatives related to study start-up activities.

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director