Job Summary (Primary function)
The Associate Director, Clinical Trial Head is accountable for all aspects of assigned clinical trials/program. The Associate Director is responsible for program level activities as assigned and is accountable for the day-to day clinical development operational plans in accordance with budget and timelines and with standard operating procedures (SOP), ICH Good Clinical Practices and any other specific country regulations.
Essential Functions of the Job (Key responsibilities)
- Accountable for development and execution of accurate operational Development Plans, including assuring harmonization across clinical trials/program.
- Assist in the development and writing of clinical Trials/program documents and manuals as appropriate
- Assist in the Clinical Research Organization (CRO) identification and selection process.
- Collaborate with Sr. Management, internal project team and CRO partners, as applicable, to prepare clinical trials/program timelines, budget and key deliverables consistent with departmental and corporate objectives.
- Plan, implement, and manage Phase I-III clinical trials, as necessary.
- Collaborate with Sr. Management to determine clinical supply requirements for clinical trials/program.
- Assist for clinical program/trials implementation including operational feasibility, resource forecast and management.
- Align the CTM, Sr. CTMs, CTS to resource the studies across the trials/program.
- Provide updates and status reports to Sr. Management, as requested.
- Contribute to the hiring plan and staffing activities including efficient on-boarding, training and mentoring of new employees.
- Maintain close collaboration with clinical development, other internal departments and external vendors.
- Maintain and develop Investigator sites and KOLs relationship.
- Provide clear objectives, ongoing feedback and end of performance review for any direct reports.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Bachelor of Science degree or a degree in a field relevant to a profession in the biopharmaceutical industry.
- Minimum of 5-7 years’ experience working in project management and/or clinical operations within the biopharmaceutical industries and/or Clinical Research Organization (‘CRO’).
- Operational, and direct managerial experience in the planning, executing and reporting of global clinical development trials.
- Experience in program management preferred.
- Must have experience in appropriate therapeutic area; preference in Oncology.
- Proven ability to lead a multi-disciplinary teams.
- Experience in developing effective relationships with key investigators.
- Good knowledge of GCPs, clinical trial design, statistics, regulatory processes, and drug development process.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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