Gilbert Meher are partnered with a high-growth, international Medical Device company in their search for a Director of Clinical Affairs.
The successful candidate will be leading a dynamic team, in the company’s office in Texas. Reporting to the VP of Clinical Affairs, the position will create effective lines of communication between the Clinical Affairs department and executive management.
This is an excellent opportunity to define and execute clinical strategies, to drive the company’s commercialization and growth objectives.
- Oversee and develop a team of Clinical Project Manager(s), and external vendors such as Core Labs, Medical Monitors, Data Management, and Biostatistics.
- Responsible for the design and development of clinical trials, protocols, timelines and budgets, in line with the company’s financial goals.
- Work closely with the VP to secure approvals from regulatory bodies such as the FDA, Health Canada, Competent Authorities, and international authorities etc.
- Develop SOPs and work instructions, ensuring that protocols and regulatory (FDA/ICH/ISO/GCP) guidelines are adhered to.
- Ensure necessary approvals from IRBs/EC’s for clinical trials, taking corrective actions to resolve any issues.
- Identify training needs and develop materials for in-house and on site use.
- Interpret and document results clearly and concisely for regulatory submissions and publications.
- Maintain relationships with investigators, researchers and thought leaders, to ensure successful clinical development programs.
- Oversee the screening and contracting with investigators, sites and vendors required for conduct of clinical trials.
- Bachelor’s degree or higher in the Life Sciences or relevant disciplines.
- 5 + years’ experience in a senior clinical management role, in the medical devices or biopharmaceutical industry, CRO or academic/hospital clinical research environment.
- 5 + years’ direct experience in clinical trial management in addition to the above.
- Sound working knowledge and understanding of GCP, ICH, ISO guidelines & FDA and applicable international regulations.
- Experience in managing staff and CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting.
- Demonstrated success in executing Phase I – III clinical trials.
- Knowledge of EDC and web-based clinical trial management tools.
- Highly proficient in MS Word, Excel, PowerPoint etc.
- Willing to travel domestically and internationally up to 30%.
- Biopharmaceutical experience would be beneficial.
For more information about this role, please contact Abigail Prudhoe at email@example.com or call +44 782 550 2645
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