Executive Director, Clinical Operations TA Delivery Head

Company: Merck Gruppe
Location: Boston
Posted on: April 1, 2025

Job Description:

Work Location: Boston, MassachusettsShift: NoDepartment: HC-RD-D Global Development OperationsRecruiter: Omar de BaryThis information is for internals only. Please do not share outside of the organization.Your Role: The Clinical Operations Therapeutic Area Delivery Head - Oncology will join the Global Development Operations (GDO) executive leadership team and report directly to the Head GDO.The Clinical Operations TA Delivery Head is accountable and responsible to:

• Develop and implement a portfolio strategy that aligns with the company's drug development goals and regulatory pathway and translate Portfolio Governance decisions into actionable portfolio delivery strategies, balancing business needs and operational priorities.
• Drive operational execution, ensuring clinical programs are delivered on time, within budget, and in compliance with GCP, ICH, FDA, EMA, and other regulatory requirements. Monitor portfolio status, anticipate risks and implement proactive mitigations strategies to ensure seamless execution.
• Provide strategic input into study design, feasibility assessments, and protocol development to optimize trial efficiency and patient recruitment.
• Implement data-driven decision-making processes using real-time trial analytics and performance metrics. Drive adoption of innovative technologies, such as decentralized trials, adaptive trial designs, and digital health solutions, to enhance trial efficiency.
• Represent Global Development Operations in cross-functional governance meetings and regulatory interactions, as well as serve as a core member in TA Development Unit Leadership Teams.
• Lead in a matrix organization, mentor, and develop high-performing clinical operations teams to drive operational excellence.
• Foster a culture of continuous improvement, innovation, and accountability within the clinical operations function.Who you are:The ideal candidate must have:
  • 15+ years of experience in clinical operations within the pharmaceutical industry, with at least 10 years in program leadership and with a proven track record of leading large, global clinical trial portfolios.
  • Extensive experience in Oncology, both in developing operational strategy and driving execution of multiple programs in parallel.
  • Extensive knowledge of regulatory requirements (FDA, EMA, PMDA, ICH-GCP) and global clinical development processes.
  • Strong experience in managing CROs and vendor partnerships in a global environment.
  • Ability to translate corporate objectives into clinical development strategies.
  • Strong collaboration skills across internal and external teams, with the ability to influence decision making in a matrix organization and leading by objectives.
  • Fluent in English (written and oral).
  • Position requires both domestic and international travel up to 40% of time.The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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Keywords: Merck Gruppe, Boston , Executive Director, Clinical Operations TA Delivery Head, Executive , Boston, Massachusetts