Director, Clinical Affairs
vor 14 Stunden
The mission of the Clinical Affairs group within Medical and Scientific Affairs is to create value for ImmunoDiagnostic Division (IDD) by providing clinical evidence for product pre-launch or post-launch across the portfolio.
Main responsibilities for the unit are:
- Own IDD clinical affairs planning, execution and reporting
- Develop timely and cost-effective clinical study strategies to support product claims
- Liaise with Regulatory Affairs organizations to execute on prioritized product registration plans in selected geographical areas
- Liaise with R&D Organization to align on product specifications to be fulfilled and patient cohorts to be targeted
- Liaise with Commercial Operations organizations to ensure desired products are available for sales on the territory
- Liase with Marketing organization to leverage on key customers and KOLs within clinical trials and support building sales supporting arguments on top of registration-related claims
Essential Responsibilities
Reporting to the VP of Medical and Scientific Affairs, the Clinical Affairs Director will be responsible for:
- Work closely with senior management to translate business commercial objectives into a global clinical affairs strategy
- Ensure successful planning, design and execution of Thermo Fisher sponsored clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance
- Develops budget for all clinical affairs projects
- Hire and develop a team of Clinical Research associates and Biostatisticians and/or collaborate with Thermo Fisher Scientific’s Clinical Research Group to build a team focused on IDD clinical studies
- Develop, maintain and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs
- Develop and ensure execution of SOPs and work instructions in compliance with regulatory (IVDR/FDA/NMPA/GCP) guidelines.
- Identify clinical training needs and develop training materials for in-house and clinical site use
**Qualifications/Requirements***
- Bachelor’s plus Master’s degrees in the Life Sciences or related disciplines.
- 8+ years of experience in a regulated industry required (e.g., medical devices, diagnostics, pharmaceuticals); experience in in-vitro diagnostics (IVD) strongly preferred
- 5+ years of people and team management experience
- Solid track record in successfully executing device/diagnostic/pharma clinical trials
- Demonstrated expert knowledge and comprehensive understanding of applicable IVDR, GCP, ICH guidelines & FDA and applicable international regulations.
- Knowledge of electronic data capture systems and web-based clinical trial management tools
- Excellent interpersonal, written / verbal communication, critical thinking and organizational skills
- Collaborative team player
- Strong program management and financial skills
- Willing & able to travel domestically and internationally, as required (up to 50%)
Travel up to 50% may be required.
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