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[Remote] Executive Director, US Site Study Start Up and Innovation Head
Note: The job is a remote job and is open to candidates in USA. Merck is a leading pharmaceutical company dedicated to improving patient outcomes. They are seeking an Executive Director to oversee the execution and oversight of local operational start-up clinical trial activities, ensuring compliance with regulations and developing innovative strategies for site engagement.
Responsibilities
- Identify and implement innovative solutions to streamline start-up timelines, leveraging technology, reengineering processes, and best practices
- Define site engagement strategy and site relationship management model
- Proactively assess potential risks and bottlenecks in study start-up, developing mitigation plans and contingency strategies to ensure successful study launches
- Build and mentor a high-performing team of study start-up professionals, fostering a culture of accountability, collaboration, and continuous improvement
- Oversee the performance management and career development of staff and effectively manage performance issues
- Work closely with US CRDs, HSMM/CRA-Manager and TA-Heads to assess program strategy and alignment of project deliverables and objectives
- Partners with Headquarters-based colleagues help drive GCTO RRO strategy, with specific focus on standards of practice for site budgeting, site contracting, Informed Consents, and management of Central IRBs and applicable Health Authorities. Create, promote, and direct a strategy for rapid start up activities
- Establish procedures and processes for all relevant activities (managing site contracts and budget negotiation and escalation, regulatory submissions and approvals; procedures and processes for managing logistics and purchasing of drugs and materials for study start up.)
- Responsible to ensure all projects are adequately resourced and tracked to ensure optimal efficiency and attainment of goals, milestones, and targets while ensuring high quality standards are maintained
- Establishing a strategy for partnering and monitoring all vendors/service providers that support operational implementation and management of Sr. COM, COM and CTC responsibilities. (Includes strategic oversight, providers, Central IRB vendors, etc.)
- Collaborates internally with CRDs, TAHs, CRA managers, Monitoring Excellence, Vendor management, Vendor Strategy and Management to develop and build the territory of principal investigators and sites
Skills
- Bachelor of Science (or equivalent)
- 15 years of experience within the Pharmaceutical Industry of which at least 12 years of experience are in a clinical trial organization including experience in all clinical trial startup and ongoing management activities and processes
- 7 years of experience in a functional management position
- Expert knowledge of clinical trial regulations (FDA, EMA, ICH-GCP) and site activation processes
- Knowledge of clinical trial operations from a clinical research site perspective
- Proven ability to manage complex projects, drive results, and influence cross-functional teams
- Exceptional communication, negotiation, and stakeholder management skills
- Strong analytical and problem-solving abilities
- Budget Management
- Clinical Trial Development
- Clinical Trial Management
- Clinical Trial Planning
- Clinical Trial Protocols
- Clinical Trials
- Clinical Trials Monitoring
- Clinical Trials Operations
- Executive Leadership
- Innovation
- People Leadership
- Regulatory Governance
- Resource Allocation
- Risk Management
- Study Start Up
- Team Development
- Master of Science or Medicine (or comparable)
- CRA experience
- Management of CRAs and familiarity with outsourcing and flexible resource models
- Experience with an innovation and study start up environment
- Demonstrated success leading large, global clinical trial start-up initiatives in a pharmaceutical or biotechnology environment
- Experience with digital platforms and technology-enabled study start-up solutions
- Experience managing personnel and processes in a matrix managed organization
- Working with multiple external partners with adequate controls, governance, and oversight
- Clinical Research
Benefits
- Medical
- Dental
- Vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
Company Overview
