Job DescriptionThe Head, PSM is a senior GCTO leadership role responsible for the strategic and operational leadership of a portfolio of clinical programs within assigned Therapeutic Areas (TAs). This role serves as a key and active participant in GCTO Leadership Team (LT) and governance bodies including: GCTO Steering Committee, GCTO Sourcing Governance Committee, GCTO Operations Review, Vendor governance, and GCD Quality & Compliance Council. This role holds single-point, end-to-end accountability for the delivery of all clinical studies within assigned TAs, from initial concept and operational planning through to final reporting and inspection readiness.
The Head, PSM will drive enterprise-wide collaboration and ensure seamless integration and strategy alignment with Clinical Development TA and CS Heads, GCTO Functional Leaders, Global Clinical Supplies and other key functions to accelerate high quality delivery of portfolio.
Key Responsibilities:1. Strategic Leadership and Alignment- Contribute to the development and execution of the GCTO vision, strategy, and goals, ensuring alignment with the broader company, Research and Development (R&D) and Global Clinical Development (GCD) strategy.
- Serve as the GCTO point of accountability for the assigned TA(s), partnering closely with GCTO Functions and GCD TA and CS Heads to provide strategic operational input into the overall clinical development plan.
- 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.
2. End-to-End Program and Study Delivery [Execution Excellence]- 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 Ops Review trials or initiate other cross-functional forum to address.
- Execution Excellence - Inspires excellence and drives reliable, high quality delivery by continuous improvement of processes and KPI driven measurement approaches to track progress, identify risks early, and execute mitigations to ensure end-to-end clinical trial delivery. Provide senior 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 the primary 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.
3. Therapeutic Area (TA) Expertise and Collaboration- This role is a highly cross functional and influential role with 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.
4. People Leadership and Development- Builds 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.
5. Operational Excellence and Modernization- 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".
6. Resourcing, Vendor Management, and Financial Stewardship- 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).
- Actively participate in broader GCD/GCTO-level vendor governance structures while proactively establishing and leading supplementary TA-specific oversight frameworks, as needed to resolve complex escalations, optimize performance, and ensure strategic alignment.
7. External Facing Leadership and Competitiveness- Represent the company as a senior operational leader in external forums, including scientific conferences, investigator meetings, and industry consortiums.
- 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.
Educational Requirements:- Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred.
- Advanced scientific degree (Master's, PharmD, PhD) in life sciences, medicine, or a related field strongly preferred.
Required Experience, knowledge, skills and abilities:- Minimum of 12 years of progressive experience in the pharmaceutical, biotechnology, or CRO industry, with a primary focus on clinical trial operations and drug development.
- Demonstrated track record of single-point accountability for the successful execution of clinical programs, including pivotal registration trials and regulatory submissions.
- Proven history of building robust talent pipelines, implementing structured mentorship/rotational programs, and cultivating future directors and program leaders.
- 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.
- Financial & Operational Stewardship: Demonstrated success managing organization budgets, optimizing resource allocation, and reducing costs while accelerating cycle times.
- Regulatory & Quality Rigor: strong knowledge of GCP/ICH and global regulatory expectations.
- 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.
Required Skills: Change Management, Change Management, Clinical Development, Clinical Risk Management, Clinical Trial Management, Clinical Trial Methodology, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Confidentiality, Continuous Monitoring, Cross-Cultural Awareness, Ethical Standards, Global Team Collaboration, High Performance Team Building, Innovation, Key Performance Indicators (KPI), Motivating Teams, Motivation Management, Multiple Therapeutic Areas, Operational Excellence, Operation Risk Management, Resource Allocation, Stakeholder Collaboration, Stakeholder Management {+ 1 more}
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.
The salary range for this role is
$310,900.00 - $489,400.00
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 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
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Hybrid
Shift:Valid Driving License: 
