Our client is a leading provider of non-invasive surgical treatments in a number of clinical areas. For their Dallas, TX office they are looking for a Director of Clinical Affairs and CRO.
You will be responsible for defining the vision and clinical strategies that will support meeting product development and commercialization objectives. The Director of Clinical Affairs is responsible for the design and successful execution of clinical trials that demonstrate medical product safety and efficacy, and ensuring that trials are conducted in full compliance to GCP and all other applicable regulatory requirements.
The Director of Clinical Affairs typically manages several Clinical Project Managers, and external vendors such as Core Labs, Medical Monitors, Data Management, and Biostatistics. You will take the leadership role for analysis and interpretation of clinical results for regulatory submissions and publications. This position reports to the Global VP.
1) BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.
2) Minimum 5 years in senior clinical management position in biopharmaceutical or device industry, CRO or academic/hospital clinical research environment.
3) Biopharmaceutical experience would provide a strong advantage.
4) Additional 5+ years direct experience in clinical trial management.
5) Solid track record in successfully executing Phase I – III clinical trials.
6) Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines & FDA and applicable international regulations.
7) Strong, hands-on manager with experience in managing clinical affairs staff and CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting.
8) Knowledge of electronic data capture systems and web-based clinical trial management tools.
9) Excellent interpersonal, written / verbal communication & organizational skills.
10) Collaborative team player.
11) Strong program management and financial skills.
12) High level computer skills required (e.g. MS Word, Excel, PowerPoint).
13) Willing & able to travel domestically and internationally, as required (up to 30%).
Strategic translation of business objectives into successful clinical requirements for clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance.
Manage and develop global internal team of Clinical Project Managers, and outside vendors as needed.
Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with regulatory authorities, and development of timeline and budget.
Manage the process of screening/qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
Direct/Manage necessary clinical trial approvals from IRBs/EC’s, and ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
Partner with VP to obtain clinical trials approvals from regulatory bodies such as the FDA, Health Canada, Competent Authorities, China, Japan, etc.
Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
Develop, maintain and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs.
Develop SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards.
Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP procedures.
Identify clinical training needs and develop training materials for in-house and clinical site use.
Provide oversight of investigator-sponsored studies.
Develops budgets for all clinical projects and adheres to company financial goals.
The Director of Clinical Affairs will work closely with senior management to translate business commercial objectives into requirements for specific clinical trials and programs. This role is responsible for the successful execution of the clinical portfolio as well as the management, growth and development of the clinical staff. The position requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge of indications. The position requires the individual to have strong leadership, problem-solving, and decision-making abilities.
Responsible for managing internal and external resources including Clinical Project Leader(s)/Manager(s), and vendors, core labs, medical monitors, data management, biostatistics, and investigational sites.