Executive Director, Clinical Operations, Oncology

Merck • North Wales, PA

3d • Hybrid

About The Position

This role is within Global Clinical Trial Operations (GCTO), specifically in the Clinical Sciences and Study Management organization (CSSM). CSSM is responsible for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, managing a grant budget exceeding $1B. The Executive Director will be responsible for the strategic planning, oversight, management, and execution of HQ-sponsored trials for an assigned Therapeutic Area Section, including local registration trials and regulatory commitments. This position also provides technical and scientific support for all clinical research trials and programs within the defined Therapeutic Area Section, applying an in-depth understanding of the R&D Division's clinical development strategy to achieve research objectives. The role involves liaising with cross-functional areas such as Global Clinical Development Therapeutic Area/Section Heads and Senior Regulatory and Safety Executives to ensure adequate staffing and support align with development priorities. Furthermore, the Executive Director is responsible for staff development, including providing vision, direction, training, and project sponsorship, ensuring performance management and career development plans are implemented, and maintaining organizational compliance with all policies and procedures. This is a highly cross-functional and influential role within Global Clinical Development (GCD).

Requirements

• Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred.
• 15+ years of relevant experience working on clinical development programs (pharma/biotech/academia/government) or equivalent combination of education and experience required.
• Extensive experience in the planning and execution of clinical trials with demonstrated ability to translate knowledge and expertise to areas at all levels within the R&D sphere of influence (Therapeutic Areas, Regional Operations, Data Management, Clinical Supplies, Functional Service Providers, and Vendors etc.).
• Demonstrated ability to effectively manage scope, time, and cost of assigned projects; is business savvy and results-oriented.
• Proven ability to lead and actively contribute to the design and implementation of cross-functional strategic, process, and improvement initiatives.
• Budget Management
• Clinical Data Management
• Clinical Data Standards
• Clinical Operations
• Clinical Studies
• Clinical Trials Operations
• Executive Leadership
• Matrix Leadership
• Oncology
• People Leadership
• Project Management
• Regional Operations
• Regulatory Governance
• Strategic Leadership
• Strategic Management
• Strategic Planning

Nice To Haves

• Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred.
• Experience within the Oncology Therapeutic Area, with a preference for experience within Lung.

Responsibilities

• Provide leadership to the designated Area within CSSM, including optimizing organizational resources, owning and optimizing key processes, talent and succession management, managing the overall operating budget, and overseeing high-priority programs and studies.
• Identify and drive enhancements and standardization of CSSM TA deliverables, tools, and processes to increase efficiencies.
• Provide leadership during risk assessments and mitigation planning for priority program execution.
• Engage with key vendor partners to align on strategy, execution, and delivery for the expanding portfolio.
• Ensure the successful execution of all headquarter-based patient clinical trials.
• Provide direction and oversight to teams in preparation for Late-Stage Development Review Committee, Operational Reviews, and Deep Dive Meetings.
• Define overall indication, program, and study clinical operational strategies, ensuring rigorous leadership across all organizational levels, managing overall study budgets, and maintaining comprehensive program and study communication with internal and external stakeholders.
• Ensure the implementation of job-related tools and systems by staff.
• Ensure the development of detailed study design specifications, medical monitoring of study data, and summarizing results for assigned R&D clinical trials.
• Represent GCTO and CSSM on strategic initiatives at all levels of the organization.
• Provide leadership to the CSSM organization as a member of the CSSM Leadership Team.
• Effectively manage resources to ensure appropriately skilled and high-performing staff are assigned to execute the Book of Business and achieve GCD and R&D objectives.
• Set clear performance standards and hold self and the organization accountable for achieving results.

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
• Annual bonus
• Long-term incentive

What This Job Offers

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