Informationen zur Anzeige:
Director Clinical Affairs (m/f/d)
14.01.2022, Fresenius Kabi
Director Clinical Affairs (m/f/d)
Leads clinical program(s) in accordance with the clinical development strategy for the clinical program(s). Applies industry standard risk based oversight of the clinical studies that are part of the clinical development program. Collaborates closely with the CRO including but not limited to guidance regarding medical and clinical development activities, i. e. education of the CRO's medical personnel, investigators and study site personnel oversees risk based medical monitoring, protocol deviations, adherence to medical monitoring plans, quality elements etc. Documents the oversight to pass inspections. His/her responsibilities include providing clinical input for all activities related to an early clinical development to mature product lifecycle management.
Leads / participates in cross-functional teams providing clinical input on behalf of the clinical team, involved in the interpretation of the clinical results and their communication to internal and external stakeholders.
Accountable for preparation of the clinical part of briefing books and regulatory documents for the interactions with the Health Authorities (HA), preparation of clinical parts of marketing authorization dossiers and responses to subsequent questions. Attendance as needed to HA meetings.
Provides input to device related clinical questions as ie human factor study protocols.
Accountable for setting the scope for clinical content of Clinical Study Protocols, Investigator Brochures, Clinical Study Reports, Clinical Modules for submission, including Integrated Summary of Efficacy, together with the safety colleagues for the Integrated Summary of Safety, pediatric study plans, and other documents as needed.
Accountable and responsible for sponsor elements for inspection readiness related to the clinical elements including respective parts of the TMF.
Taking as needed clinical leadership role in meetings with the HA presenting the Company position regarding the clinical programs and the strategy for its achievement.
Contributes to the data disclosure of clinical trials' results including but not limited to publications.
Assures high quality input to budget for the clinical areas and manages related activities (ie contracts with consultants, invoices etc).
Contributes to due diligence activities as required.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research related to his/her work activities.
Medical Doctor is preferred, alternatively a PhD in a biological area, Vet med
At least 5 years for a MD, 7 years for a PhD of clinical development experience in the pharmaceutical industry or CRO preferably in biotechnology in a global role, leading clinical development activities from early stage development to submission and approval by the HA.
Job Specific Competencies & Skills:
Ability to lead and manage complex clinical program(s)
Ability to assess risks and provide innovative solutions related to the assigned clinical program(s) and to present risk-benefit assessment to the clinical team and senior management if requested
Ability to lead cross-functional teams in the matrix model and to motivate by example the other team members with a 'can do' attitude
Willingness to take accountability, hands on including administrative and operational tasks with an open mindset
Ability to work constructively without micromanagement with CRO's with a resource efficient mindset
Excellent communication skills to represent the organization during interaction with HA, external stakeholders, including key opinion leaders
High commitment for achievement the Business unit goals
Ability to think strategically and drive clinical programs with the right decision-making mindset considering short and long-term impact of his/her decisions
Work experience in a multinational environment
Knowledge of clinical strategies, clinical trial methodology, including statistics and relevant regulatory policies preferably in the biosimilar field of development
Excellent oral and written command of English language