Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit a (Sr.) Clinical Program Manager, Translational/ Early Development to lead and direct execution of clinical studies for assigned clinical programs in translational research/ early stage development.
- Bachelor’s degree or international equivalent required
- Translational/ early stage development experience required
- Plan and manage the overall execution of the assigned clinical program to meet necessary quality, budget and timelines, including making or recommending operational strategies and/or decisions in support of achieving clinical program objectives
- Represent Clinical Operations globally as a member of the Global Development Team, working closely with GDT Leadership to ensure program objectives are met
- Matrix leader of cross-functional global Clinical Program Team responsible for operational strategy for assigned clinical program; serves as main point of contact for regional, global or cross functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues
- Responsible for program budget planning and accountable for external spend related to program execution.
- Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program, including escalation of issues to governance committees when warranted
- Provide program-level direction to clinical study manager(s) for the development of study management plans including enrollment models, risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner
- Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents
- Collaborates with Associate Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program
- Support functional strategic initiatives and processes managed by Clinical Services Group
- Responsible for the operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling, in collaboration with Director, Clinical Operations
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.