Executive Director, US Clinical Operations

Translational Medicine

Translational Medicine (TMed) leverages multidisciplinary expertise to guide decision-making throughout the drug development process, driving the most promising therapeutic candidates forward. We partner with stakeholders to strategically shape our pipeline and advance breakthrough medicines from discovery to late-stage development and beyond. Through cross-functional collaboration, we integrate data to derive insights across functional and therapeutic areas, fostering connectivity and fueling innovation.

The clinical organization within Translational Medicine (TMed) is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and Late-Stage Clinical Research, and is accountable for all scientific, operational, and technical aspects of TMed HQ-sponsored clinical trials. The Head of TMed US Clinical Operations will provide strategic leadership and managerial oversight, leading the group to deliver on the TMed clinical portfolio (>

100 trials and program level deliverables annually across multiple therapeutic areas, including multi-country / center patient trials). The Executive Director will develop / support an empowered organization that can navigate in a matrixed environment and adjust quickly to business needs including new / evolving processes and technology. The incumbent will be responsible for ensuring the organization drives successful execution of all operational components of clinical programs using strong project management, leadership, organizational and communication skills while ensuring GCP and quality standards are met and within agreed timelines and budgets. The incumbent will assure alignment of the operations activities with the overall priorities of the department, division, and company. They will be responsible for ensuring staff are provided with appropriate vision, direction, training, and sponsorship of projects and initiatives. The incumbent will ensure performance management and career development plans are implemented by direct supervisors and that the entire organization is compliant with all policies and procedures. The ideal candidate demonstrates a growth mindset and uses sound judgment to balance risks and trade-offs. They bring a proactive solutions-oriented approach and a strong commitment to ensure continual optimization of our organization to meet Research and Development's (R&D) mission. They foster constructive debate, respectfully challenge assumptions, and communicate with courage and candor when representing TMed in higher level cross-functional interactions. The Executive Director reports to the Senior Vice President / Head of Translational Medicine and sits on the TMed Leadership Team. This role is a highly cross-functional and influential role within TMed and with cross-functional partners.

Primary Responsibilities

• Leadership & Culture : Provide strategic and motivational leadership to TMed US Clinical Operations, fostering an inclusive, engaging, and high-performance culture. Lead organizational change initiatives, ensuring adaptability to evolving internal and external environments. Promote diversity of thought through empowering staff to speak up, challenge the status quo, and contribute to continuous improvement.
• Portfolio & Operational Oversight : Oversee execution of all TMed clinical trials, ensuring alignment with portfolio priorities and R&D objectives. Drive operational excellence through process optimization, knowledge sharing, and continuous improvement initiatives. Maintain compliance with departmental SOPs and quality standards.
• Resource & Talent Management : Define functional capability needs and allocate resources to meet business objectives. Manage hiring, succession planning, and professional development to build a skilled, high-performing team. Support a learning environment through coaching, mentoring, and feedback.
• Stakeholder Engagement : Serve as the escalation point for issues across programs and operations. Build strong relationships with cross-functional partners. Respectfully challenge partners and draw appropriate boundaries, when necessary. Represent TMed on strategic initiatives, committees, and task forces.
• Strategic Planning & Industry Awareness : Lead strategic planning and execution for clinical operations to meet increasing complexity / demands of the business with innovative thinking and experimentation. Stay current on industry trends and best practices in early-phase clinical development.

Education Requirement :

Bachelor's Degree with a concentration in a scientific discipline or Advanced degree (MS or PhD) in a scientific discipline.

Required Experience and Skills :

Bachelor's degree with 15+ years of relevant experience working on clinical development programs (pharma / biotech / academia / government), or an equivalent combination of education and experience, with advanced degree : MS degree with 13+ years of relevant clinical development experience, or PhD degree with 11+ years of relevant clinical development experience. 5+ years' experience building high performing teams including attracting, developing, and retaining talent. Extensive experience in planning and execution of clinical trials (including Phase 1 and 1b / 2a) and programs with demonstrated ability to translate knowledge and expertise to areas at all levels within the R&D sphere of influence. Mastered knowledge of clinical drug development, GCP and ICH guidelines, and the clinical regulatory environment. Demonstrated ability to influence senior level stakeholders and drive strategic decisions in support of the portfolio within a matrixed organization. Proven ability to drive change, challenge current ways of thinking, build shared understanding, and find constructive solutions. Proven ability to lead / actively contribute to design and implementation of cross-functional strategic, process, and improvement initiatives. Experience in strategy development, planning, and implementation. Demonstrated ability to effectively manage scope, time, and cost of assigned projects and portfolio.

Preferred Experience and Skills :

Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training. In addition to Ph1 clinical trial experience, late-stage clinical trial experience, and experimental / discovery medicine clinical trial experience, e.g., clinical drug development, clinical trial management, (including Phase 1 and 1b / 2a); GCP and ICH requirements.

Required Skills :

Clinical Development, Clinical Trials, Cross-Functional Teamwork, ICH GCP Guidelines, Innovation, Leadership, People Leadership, Stakeholder Engagement, Stakeholder Management, Strategic Leadership, Strategic Planning, Strategy Development, Succession Planning.

Preferred Skills :

Current Employees apply HERE. Current Contingent Workers apply HERE. US and Puerto Rico Residents Only : Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit : EEOC Know Your Rights. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $250,800.00 - $394,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of 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. You can apply for this role through https : / / jobs.merck.com / us / en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the