Executive Director, Clinical Operations, Oncology

MSD • North Wales, PA

3d • Hybrid

About The Position

Global Clinical Trial Operations (GCTO) is a global organization with over 9500 people operating in 47 countries. The Clinical Sciences and Study Management organization (CSSM) is a sub-functional unit within GCTO, divided into three therapeutic clusters, with over 1000 people, and is accountable for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, including a grant budget more than $1B. Key activities for this role include the strategic planning, oversight, management and execution of HQ-sponsored trials for the assigned Therapeutic Area Section, including local registration trials and regulatory commitments. The position is also directly responsible for the technical/ scientific support of all clinical research trials and programs within the defined Therapeutic Area Section. Applies an in-depth understanding of our Research and Development Division's clinical development strategy in the implementation of short and long-term research objectives. Liaises with cross functional areas supporting clinical development including Global Clinical Development Therapeutic Area/ Section Heads and Senior Regulatory and Safety Executives 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 with GCD.

Requirements

• 15+ years of relevant experience working on clinical development programs (pharma/biotech/academia/government) 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 the R&D 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.
• Budget Management
• Clinical Data Management
• Clinical Data Standards
• Clinical Operations
• Clinical Studies
• Clinical Trials Operations
• Executive Leadership
• Matrix Leadership
• Oncology
• People Leadership
• Project Management
• Regional Operations
• Regulatory Governance
• Strategic Leadership
• Strategic Management
• Strategic Planning

Nice To Haves

• Experience within the Oncology Therapeutic Area, with a preference for experience within Lung clinicaltrialjobs

Responsibilities

• Provide leadership to the designated Area within CSSM. This includes continual optimization of the organizational resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies.
• Identify and drive enhancements/standardization of CSSM TA deliverables and tolls/processes to increase efficiencies.
• Provide leadership during conduct of risk assessments and mitigation planning for priority program execution.
• Engagement with key vendor partners to align on strategy, execution, and delivery for the expanding portfolio.
• Ensure the successful execution for all headquarter based patient clinical trials.
• Provides direction and oversight to teams in preparation for Late-Stage Development Review Committee, Operational Reviews, and Deep Dive Meetings.
• As CSSM has accountability for the overall success of the studies, this is achieved by defining the overall Indication, program and study clinical operational strategies, ensuring rigorous leadership across all levels of the organization, overall study budget management and comprehensive program and study communication with all internal and external stakeholders.
• Ensure implementation of job related tools and systems by staff.
• Ensure implementation of job-related tools and systems by staff.
• In addition, ensure the development of detailed study design specifications, medical monitoring of study data and summarizing results for assigned Research and Development clinical trials.
• Represent GCTO and CSSM on strategic initiatives at all levels of the organization.
• Provide leadership to the CSSM organization as a member of the CSSM Leadership Team.
• Effectively manage resources to ensure appropriately skilled and high performing staffs are assigned to effectively execute on the Book of Business and achieve GCD and Research and Development objectives.
• Sets clear performance standards and holds self and organization accountable for achieving results.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive