Director of Clinical Affairs will be responsible for defining the vision and clinical strategies that will support meeting the organizations product development and commercialization objectives.
- Strategic translation of business objectives into clinical requirements for clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance.
- 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.
- Obtain necessary clinical trial approvals from IRBs/EC’s and regulatory bodies such as the FDA, Health Canada, and Competent Authorities.
- Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Maintain surveillance of published literature and clinical results for Anika and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
- 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/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.
- BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.
- Minimum 5 years in senior clinical management position in the Medical device industry, CRO or academic/hospital clinical research environment.
- Additional 3+ years direct experience in clinical trial management in Spine space.
- Solid track record in successfully executing Phase I – III clinical trials.
- Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
- Strong, hands-on manager with experience in managing clinical affairs staff and CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting.
- Knowledge of electronic data capture systems and web-based clinical trial management tools.
- Excellent interpersonal, written / verbal communication & organizational skills.
- Collaborative team player.
- Strong program management skills.
- High level computer skills required (e.g. MS Word, Excel, PowerPoint).