Executive Director, Program and Study Management, Oncology

Job Description

Global Clinical Trial Operations (GCTO) is a global organization with over 10000 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 divisions 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.

Key Responsibilities and Accountabilities:

Strategic Leadership and Alignment

• 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.

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 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.

Therapeutic Area (TA) Expertise and Collaboration

• 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 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.

People Leadership and Development

• 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.

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.

• 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).

• External Facing Leadership and Competitiveness

• 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 companys capabilities are best-in-class.

Requirements

• Bachelors 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.

Required Skills:

Preferred Skills:

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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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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