Executive Director, Program and Study Management, Immunology and Neurosciences

MSD•Rahway, NJ

7d•Hybrid

About The Position

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.

Requirements

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.
Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations.
Strong knowledge of GCP/ICH and global regulatory expectations.
Proven history of developing talent and building robust talent pipelines.
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

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
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Responsibilities

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.
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.
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.
Champion and represent GCTO needs / operational feasibility.
Proactively builds and sustains strategic internal and external relationships to accelerate PSM priorities.
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.
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.