Director, Clinical Affairs

Veranex est le seul fournisseur de services technologiques véritablement complet et mondial dédié à l'industrie des technologies médicales. Veranex offre des conseils d'experts de la conception à la commercialisation, y compris la conception et l'ingénierie des produits, le développement préclinique et clinique, la gestion des données, l'accès au marché, les affaires réglementaires et l'assurance qualité. Veranex permet d'accélérer la mise sur le marché, de contrôler les coûts de développement, d'atténuer les risques de développement et d'accélérer l'évaluation de la viabilité du marché. À chaque étape, les clients de Veranex réalisent des gains de temps et d'argent, tandis que nos solutions complètes unifient l'ensemble du processus de développement. Veranex s'associe aux entreprises les plus influentes du monde dans le domaine des sciences de la vie et des dispositifs médicaux pour rechercher, concevoir, développer et commercialiser de nouvelles technologies et de nouveaux traitements dans le domaine de la santé, afin de faire progresser les soins aux patients.

About This Role:

Veranex has an exciting opportunity to join our team as a Director of Clinical Affairs. You will be part of a team working to improve lives globally through medical technology innovation. The Director of Clinical Affairs provides leadership and strategic business support to clinical operations staff. Oversees, manages, coordinates, and prioritizes the management of Clinical Affairs.

What You Will Do:

• Establishes, implements, and directs clinical study projects for medical device clients.
• Participates in the planning, development, and execution of clinical studies.
• Oversees the development of clinical dossiers/reports supporting regulatory submissions and provides clinical direction to development teams.
• Establishes and directs clinical operations to ensure compliance with applicable laws, regulations, and company standard operating procedures (SOPs) and policies governing clinical studies.
• Manages and provides leadership to clinical affairs team, including coordinating program allocations and priorities, training, performance management, professional development, and coaching. Organizes clinical affairs staff to accomplish goals efficiently.
• Achieves staff results by communicating job expectations; planning monitoring and appraising job results; coaching and counseling employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
• Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to development of clinical reports as applicable, clinical expertise related to regulatory authority submission questions, clinical strategy, study design.
• Leads continuous improvement and change.

Required Skills/Qualifications

• 8+ years of relevant experience, including 3-5 years as a functional manager

• Bachelor’s or Master’s degree in a life sciences or related discipline

• Experience in the medical device industry
• In-depth knowledge of clinical research and the product development process
• In-depth knowledge of GCP guidelines, standards, and applicable regulations and procedures
• Strong knowledge of medical and anatomical terminology
• In-depth knowledge of company people management policies and procedures, including hiring, performance management, corrective action, and compensation administration
• Advanced people management and mentoring skills including coaching, interviewing, and providing feedback and recognition
• Advanced leadership skills including change management, people management, strategic thinking and influencing
• Excellent oral and written communication skills
• Expert ability to structure a scalable team to promote quality deliverables
• Advanced ability to interface successfully with physicians/clinical staff and familiar with hospital/clinical environments

Preferred:

• Experience working within a clinical research organization (CRO)

Veranex a souscrit au principe de l'égalité des chances et interdit toute forme de discrimination. Tous les candidats qualifiés seront pris en considération pour un emploi, sans distinction de race, de couleur, de religion ou de croyance, de sexe (y compris la grossesse, l'identité de genre ou l'expression de genre), d'orientation sexuelle, de statut parental ou marital, de handicap, d'âge, de statut d'ancien combattant protégé, d'origine, sociale ou ethnique, ou de toute autre caractéristique protégée par la loi.