Global Clinical Development Associate Director

9 hours ago

Collegeville, Pennsylvania, United States GSK Full time
Job Title: Global Clinical Development Associate Director

We are seeking a highly experienced and skilled Global Clinical Development Associate Director to join our team at GSK. As a key member of our Clinical Operations department, you will be responsible for leading the design, execution, and reporting of clinical trials, as well as providing strategic leadership and guidance to project teams and matrix teams.

Key Responsibilities:
  • Develop and implement global study delivery strategies, including country selection, diversity, patient engagement, and recruitment plans.
  • Drive assessment, selection, engagement, management, and oversight of vendors.
  • Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and GSK SOPs.
  • Make decisions that balance risk and benefit, taking action to mitigate risk where necessary.
  • Work with matrix partners, asset lead, and manager to develop and manage study-level budgets within project allocation.
  • Prepare materials for governance and financial review cycles and provide expert clinical operational input into protocol development.
  • Lead and conduct investigator meetings and other study-related meetings, and participate in governance meetings as necessary.
  • Identify and communicate resource gaps for assigned studies.
  • Lead risk management and quality efforts to ensure study compliance and inspection readiness.
  • Partner with Data Management and Clinical Sciences to develop data cleaning strategies and collaborate with Oncology-aligned staff to deliver Clinical Study Reports.
  • Work with Oncology patient councils to develop patient-centric documents and address patient burden.
Requirements:
  • Bachelor's degree in life sciences or related discipline.
  • Extensive clinical development experience, equivalent to 6 years as a global study leader, with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
  • Proven operational experience leading global oncology clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP.
  • Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
  • Proven leadership skills, influencing, and negotiation skills.
  • Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans, and manage change.
Preferred Qualifications:
  • Oncology phase III global registrational study leadership experience.
  • Proven clinical development experience across all phases of development (I-IV).
  • Experience with innovative trial design (platform, basket, umbrella, adaptive designs) and decentralized trials (DCT) initiatives.
  • Highly developed communication skills, promoting effective decision-making and conflict management.
  • Proven expertise in proactive issue identification and solution development for cross-functional matrix teams.
  • Creative thinker able to modernize clinical delivery, leverage external technology, and networks to deliver value.

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