Executive Director, US Site Study Start Up and Innovation Head

Merck • North Wales, PA

1d • Remote

About The Position

This role is accountable for the execution and oversight of local operational start up clinical trial activities in compliance with ICH/GCP and US regulations. This position will have end to end accountability of US Site and Study Start Up as well as develop new, innovative strategies and approaches for site validation and engagement (including site scouting). This role will create new ways of working to support territory development to ensure the efficient, timely, and compliant start-up of clinical studies, collaborating closely with cross-functional teams to accelerate clinical development and advance our company's mission of improving patient outcomes. This role will ensure adherence to company policies and procedures with quality standards internally and externally. This role will have ownership, oversight and impact on local regulatory and financial compliance and for out-tasking as applicable.
This role oversees teams and functions critical to clinical trial start-up and site engagement. The individual will manage a subset of CRA Managers and CRAs who are dedicated to validating clinical trial sites, as well as the Site Relationship Management (SRM) Organization, ensuring robust site relationships and operational excellence. Additionally, the role encompasses direct management of Senior Clinical Operation Managers (Sr. COMs), Clinical Operation Managers (COMs), and Clinical Trial Coordinators (CTCs). Strategic leadership is also provided for the Site Relationship Managers, guiding their approach to building and sustaining site partnerships. Furthermore, the role is responsible for driving innovative strategies in territory development, including oversight of the territory development lead, and for crafting approaches to “just in time” site management and site engagement, ensuring agility and responsiveness in clinical trial operations.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

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