Franchise Clinical Operations Development Lead
J
JobgetherPharmaceutical or Biotechnology
Based in United StatesFull-TimeSenior
SalaryAnnual U.S. base salary range of $268,000–$368,500
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Job Details
- Languages
- English
- Experience
- 15+ years of relevant experience in clinical development
- Required Skills
- Change ManagementBudget managementRisk Management
Requirements
- Bachelor’s or university degree in a medical, pharmaceutical, biological, biomedical, veterinary, or related field; PhD is a plus.
- 15+ years of relevant experience in clinical development, including clinical monitoring and global trial management.
- Proven leadership experience in pharmaceutical or biotechnology industry, including direct people management.
- Demonstrated expertise in planning and executing clinical development strategies across complex programs.
- Experience building, leading, mentoring, and developing teams with diverse functional expertise.
- Strong experience working within outsourced clinical development models, including CRO and vendor management.
- Thorough knowledge of ICH-GCP guidelines and applicable clinical research regulations.
- Demonstrated financial acumen, including overseeing clinical budgets and resource planning.
- Strong expertise in change management, risk identification, and complex problem solving.
- Exceptional leadership, communication, and stakeholder-management capabilities.
- Full professional proficiency in written and verbal English.
Responsibilities
- Lead and oversee Clinical Operations Development Leads responsible for clinical activities across assigned therapeutic indications.
- Oversee the creation and execution of Clinical Development Plans across the franchise.
- Serve as the senior clinical operations point of contact for the franchise, providing strategic operational guidance.
- Identify franchise-level risks, dependencies, and opportunities, establishing mitigation strategies.
- Ensure clinical programs are executed in accordance with ICH-GCP requirements and applicable regulations.
- Support CRO and vendor selection and oversight to maintain effective external partnerships.
- Review and contribute to key clinical and regulatory documents, including Investigator Brochures and critical submissions.
- Oversee clinical trial budgets, timelines, and resource requirements.
- Lead, mentor, and develop Clinical Operations Development Leads through recruitment, training, and coaching.
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