Executive Director, Program and Study Management, Immunology and Neurosciences
MSD Malaysia
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Benefits offered by this job
Job summary
Merck & Co. is seeking a senior leader for Global Clinical Trial Operations. You will translate TA objectives into robust operational strategies and guide cross-functional teams to execute HQ-sponsored trials, including regulatory commitments, on time and within budget.
This role emphasizes AI-driven risk monitoring, continuous improvement, and strong GCP/ICH compliance across all trial phases, with leadership for late-stage development reviews and inspections.
Qualifications
- Deep experience in planning and execution of clinical trials.
- Ability to translate TA objectives into operational strategies.
- Proven leadership of global, cross-functional teams.
Responsibilities
- Translate scientific objectives into executable operational strategies.
- Lead end-to-end delivery of clinical programs on time and within budget.
- Ensure program milestones are met with KPI/KQI monitoring.
- Drive modernization with AI-driven insights and automation.
Skills
Education
Job description
Job Description Global Clinical Trial Operations (GCTO) is a global organization with over 10,000 people operating in 50 countries. The Program and Study Management organization is a sub-functional unit within GCTO, divided into therapeutic clusters, with approximately 500 people, and is accountable for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, including a grant budget of more than $1B.
Key activities for this role include the strategic planning, oversight, management and execution of HQ-sponsored and acquired-outsourced trials for the assigned Therapeutic Area Section, including local registration trials and regulatory commitments.
Applies an in-depth understanding of our research division’s clinical development strategy in the implementation of short and long-term research objectives.
Liaises with functional areas supporting clinical development across GCTO, including Global Clinical Development Therapeutic Area/ Section Heads, Global Clinical Supplies and other key functions to ensure staffing and support is consistent with development priorities.
Responsible for ensuring that members of the staff are provided with appropriate vision, direction, training, and sponsorship of projects and initiatives.
Ensures performance management and career development plans are implemented by direct supervisors and that the entire organization is compliant with all policies and procedures.
This role is a highly cross-functional and influential role within GCD.
Translate scientific and TA objectives into robust, executable operational strategies for all clinical programs and studies.
Guide GCTO teams to understand the competitive landscape, the scientific rationale for development programs, and the long-term vision for assets.
Full accountability for the operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and with the highest standards of quality.
Ensure proactive cross-functional collaborations to develop robust trial delivery strategies (e.g., via Product Development Teams, Clinical Sub Teams, deep dives, immersion meetings,…); assess trial delivery risk each month to bring to GCTO Operational Reviewer initiate other cross-functional forum to address.
Execution Excellence – Inspires excellence and drives reliable, high-quality end to end trial delivery through continuous improvement of processes and KPI driven measurement approaches to track progress, identify early risks, and execute mitigations.
Provides oversight for all phases of clinical trial management, ensuring performance against key indicators (KPIs) and key quality indicators (KQIs) across domains such as: Product and Major Milestone delivery Cycle Times: Including Time to First Patient In (FPI), Time to Site Ready 80%, Site Activation Time, and Database Lock Time.
Enrollment, Retention, and Data Quality On time, within budget delivery of last patient in (LPI) Quality: Including Protocol Deviation Rate, Data Entry / Query metrics, Issue Management, eTMF compliance, CV/Org Charts, Training.
Drive alignment of CtQ factors at program level.
Leverage predictive analytics and AI-driven insights to proactively identify, monitor, and mitigate operational risks, ensuring program milestones are met.
Act as key escalation point for resolving complex operational issues affecting program and study delivery; working across functional leaders to support teams.
Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements.
Ensure readiness and leadership for GCD late-stage development reviews, GCTO Ops review, inspections and audits.
This role is a highly cross functional and influential role within Global Clinical Development.
Serve as the key operational partner to Clinical leadership, ensuring GCTO capabilities and strategies are fully integrated to meet the needs of the development pipeline.
In turn, champion and represent GCTO needs / operational feasibility.
Networking & Partnerships – Proactively builds and sustains strategic internal and external relationships to accelerate PSM priorities.
Key internal stakeholders include Clinical Scientists, Clinical Directors, Biostatistics, and GCTO Functions.
Ensure a deep understanding of the science and strategic context of the assigned TAs to inform and challenge operational strategies effectively and to motivate teams.
Build organizational talent and creates a work environment where teams and individuals can reach their full potential.
Provide visible, hands‑on leadership for a global team of program and study management professionals, fostering a culture of accountability, collaboration, operational excellence, quality and continuous improvement.
Empower teams to identify bottlenecks and allocate resources effectively.
Build and develop a high‑performing team through robust on‑boarding, continuous education of staff, structured mentorship and people development as well as effectively managing resources.
Set clear performance expectations, hold leaders accountable for outcomes and behaviors, and champion the modernization of operations.
Recruit, resource plan, and build capabilities – including talent reviews, succession planning, and targeted development actions.
Sponsor career development pathways that attract, retain and grow talent.
Champion a positive and inclusive work environment that encourages cross‑functional teamwork, innovation, and professional growth.
Provide guidance to line managers on building and leading high‑performing teams, managing resources effectively, and developing talent within the function.
Champion the modernization of clinical trial operations by identifying and implementing innovative processes, simplification and AI- and Automation-enabled solutions to enable proactive, predictive, and efficient trial management, enhancing overall quality, efficiency and speed.
Ensure PSM processes are state of the art, agile and built with quality by design to ensure implementation.
Ensure awareness of enterprise initiatives, drive adoption and champion the “why”.
Accountable for the effective planning and management of all resources (headcount and operating budget) for the assigned TA.
Drive program‑specific vendor strategies building collaborative partnerships tailored to the scientific and operational complexities of the portfolio.
This includes providing rigorous oversight of vendor delivery and driving mutual accountability through the continuous monitoring of robust Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).
Build and maintain a strong industry network.
Stay abreast of the external landscape, including industry trends, new regulations, and competitor activities, to ensure the company maintains a leading and competitive position in clinical development.
Leverage knowledge of industry-wide AI adoption and operational frameworks to inform strategy and ensure the company's capabilities are best‑in‑class.
- Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred.
- Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred.
- 12+ years of relevant experience working on clinical development programs (pharma/biotech/CRO) 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 organizational 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.
- Expertise in the designated TA with understanding of the specific operational challenges of the TA.
- Digital & AI Leadership: Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations.
- Regulatory & Quality Rigor: strong knowledge of GCP/ICH and global regulatory expectations.
- Proven history of developing talent and building robust talent pipelines.
- Matrix Influence: Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams.
- Artificial Intelligence (AI)
- Clinical Development
- Clinical Trial Planning
- Clinical Trials
- Digital Leadership
- Executive Leadership
- Global Team Collaboration
- Good Clinical Practice (GCP)
- ICH GCP Guidelines
- Immunology
- Key Performance Indicators (KPI)
- Matrix Leadership
- Neuroscience
- Regulatory Requirements
- Strategic Leadership
- Artificial Intelligence (AI)
- Clinical Development
- Clinical Trial Planning
- Clinical Trials
- Digital Leadership
- Executive Leadership
- Global Team Collaboration
- Good Clinical Practice (GCP)
- ICH GCP Guidelines
- Immunology
- Key Performance Indicators (KPI)
- Matrix Leadership
- Neuroscience
- Regulatory Requirements
- Strategic Leadership
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.
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
The salary range for this role is $255,800.00 - $402,700.00. 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.
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
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