Senior Director, Clinical Operations
BioInvent International AB / Biologjobb / Lund
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hela Sverige Visa alla jobb hos BioInvent International AB i Lund This position leads clinical operations programs, within the growing portfolio, providing vision, management, and daily execution. Responsibilities include operational leadership and successful execution of clinical trials according to ICH GCP regulatory guidelines, oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables; Specific responsibilities include:
• Contribute to strategic planning to ensure highly optimized clinical development plans for the company's projects.
• Ensure operational feasibility of clinical development plans and scenarios, including development and management of timelines, budget and resource requirements.
• Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and the company's SOPs.
• Drive clinical research activity including resourcing, staffing, and direction and action plans with investigational sites, CRAs, and CROs.
• Determine patient recruitment strategies, operational feasibility and implementation of study/program objectives
• Guide and manage vendors throughout the life of clinical projects.
• Coordinate the preparation and finalization of IND submissions and other regulatory documents
• Provide technical expertise for the development of clinical documents, including prioritizing, authoring, and approving study activities (i.e. protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
• Develop the infrastructure to support sophisticated clinical trials.
• Coordinate closely with all internal stakeholders to ensure operational excellence.
Qualifications
• Scientific or healthcare background and 15+ years of clinical operations experience gained working in the pharmaceutical or biotechnology industry
• Experience in the development of antibodies and biologics
• Supervisory experience managing and guiding clinical operations staff
• Experience in a hands-on early development role within a small organization is a plus.
• Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors.
• Proven track record of planning, conducting and managing clinical studies
• Experience managing clinical operations for drugs in oncology/hematology
• Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
• Expertise in the areas of drug development, operations and strategic planning
• Experience with submissions of investigational new drug
• Experience interacting with US FDA is highly preferred.
• Expert and comprehensive understanding of country specific pharmaceutical standards, FDA, ICH, and GCP requirements (and/or equivalents), principles, concepts, industry practices, and standards, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs
• Thorough knowledge of data management, data review and analysis, and drug safety and pharmacovigilance.
• Effective communication and interpersonal skills
• Position may require occasional evening and/or weekend commitment
• Position requires international travel
• An entrepreneurial and open mind capable of accommodating to rapid change is a must.
BioInvent is a research-based pharmaceutical company focused on discovery and development of innovative antibody-based drugs against cancer. BioInvent also develops antibody-based drugs in collaboration with partners who finance the development of new drugs and provide BioInvent with the right to milestone payments and royalties on sales.
Read more:
www.bioinvent.comPubliceringsdatum2017-07-20Så ansöker duSista dag att ansöka är 2017-08-24
Ange följande referens när du ansöker: Clinical Operations
FöretagBioInvent International AB
AdressBioInvent International AB
Sölvegatan 41
22370 LUND
KontorsadressSölvegatan 41
Jobbnummer 3611184
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