Director, Clinical Affairs

2 weeks ago

Gothenburg, Västra Götaland, Sweden Veranex Full time

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

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 is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

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